DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

__________________________________________________________________________________________________________________________

Food and Drug Administration

10903 New Hampshire Avenue
Document Control Center – WO66-G609
Silver Spring, MD 20993-0002

Toshiba Medical Systems Corporation September 21, 2016

Ə2UODQGR7DGHR-U
Manager, Regulatory Affairs
Toshiba America Medical Systems, Inc.
2441 Michelle Drive
TUSTIN CA 92780

Re: K161843
Trade/Device Name: Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: II
Product Code: IYN, IYO, ITX
Dated: September 14, 2016
Received: September 15, 2016

Dear Mr. Tadeo:

We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability
warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
it may be subject to additional controls. Existing major regulations affecting your device can be
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act’s requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2— Orlando Tadeo, Jr.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note
the regulation entitled, “Misbranding by reference to premarket notification” (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the
Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)
796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

For
Robert Ochs, Ph.D.
Director
Division of Radiological Health
Office of In Vitro Diagnostics
and Radiological Health
Center for Devices and Radiological Health

Enclosure
 DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: January 31, 2017
Indications for Use See PRA Statement below.

510(k) Number (if known)

K161843
Device Name

Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

Indications for Use (Describe)

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800
Model TUS-AI800 and Aplio i700 Model TUS-AI700 are indicated for the
visualization of structures, and dynamic processes with the human body
using ultrasound and to provide image information for diagnosis in the
following clinical applications: fetal, abdominal, intra-operative
(abdominal), pediatric, small organs, trans-vaginal, trans-rectal,
neonatal cephalic, adult cephalic, cardiac (both adult and pediatric),
peripheral vascular, transesophageal, musculo-skeletal (both conventional
and superficial) and laparoscopic.

Type of Use (Select one or both, as applicable)

✔ Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number.”

FORM FDA 3881 (1/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: __________________
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal N N N N 2 N N N N N N N N N 6,8
Abdominal N N N N N 2,3 N N N N N N N N N N N N N 4,5,6,7,8
Intra-operative (Abdominal) N N N N 2 N N N N
Intra-operative (Neuro)
Laparoscopic N N N N 2 N N N N N
Pediatric N N N N N 2,3 N N N N N N N N N N N 6,8
Small Organ (Note 1) N N N N 2 N N N N N N N N N N N 6
Neonatal Cephalic N N N N N 3 N N
Adult Cephalic N N N N N 3 N
Trans-rectal N N N N 2 N N N N N N N N N 8
Trans-vaginal N N N N 2 N N N N N N N N N 8
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) N N N N 2 N N N N N N N N N N 6
Musculo-skeletal (Superficial) N N N N 2 N N N N N N N N N N 6
Intravascular
Other (Specify)
Cardiac Adult N N N N N 3 N N N 7
Cardiac Pediatric N N N N N 3 N N N 7
Intravascular (Cardiac)
Trans-esoph. (Cardiac) N N N N N 3 N N
Intra-cardiac
Other (Specify)
Peripheral vessel N N N N N 2 N N N N N N N N N N 6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PSI-30BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N N 3 N N N N
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N N 3 N N N N
Small Organ (Note 1)
Neonatal Cephalic N N N N N 3 N N
Adult Cephalic N N N N N 3 N
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult N N N N N 3 N N N 7
Cardiac Pediatric N N N N N 3 N N N 7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PSI-70BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N N 3 N N N
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N N 3 N N N
Small Organ (Note 1)
Neonatal Cephalic N N N N N 3 N N
Adult Cephalic N N N N N 3 N
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult N N N N N 3 N N N 7
Cardiac Pediatric N N N N N 3 N N N 7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PST-25BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P P 3 N P N
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 N P N
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 N P
Adult Cephalic P P P P P 3 P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 N P P
Cardiac Pediatric P P P P P 3 N P P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PST-30BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P P 3 N P N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 N P N
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P
Adult Cephalic P P P P P 3 P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P 7
Cardiac Pediatric P P P P P 3 P P 7
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PST-50BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P P 3 N P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P P 3 N P
Small Organ (Note 1)
Neonatal Cephalic P P P P P 3 P
Adult Cephalic P P P P P 3 P
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P P P P P 3 P P
Cardiac Pediatric P P P P P 3 P P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVI-475BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal N N N N 2 N N N N N
Abdominal N N N N 2 N N N N N N N N 6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N 2 N N N N N N N 6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVI-475BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal N N N N 2 N N N N N
Abdominal N N N N 2 N N N N N N N N N 4,5,6,7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N 2 N N N N N N N 6
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-375BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal P P P P 2 P P P N P
Abdominal P P P P 2 P P P P P P P P P 4(N), 5(N), 6(N), 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P P P P P 6(N)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-375SC
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal P P P P 2 P P P N P 6(N)
Abdominal P P P P 2 P P P P P P P P P 4(N),5(N),6(N),7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P P P P P 6(N)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-382BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal P P P P 2 P P P N P P 6(N)
Abdominal P P P P 2 P P P P P P P 6(N),7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P P P P P 6(N)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-674BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal P P P P 2 P P P P P
Abdominal P P P P 2 P P P P P 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P P P
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-675MVL
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal P P P P 2 P P P N P P P P 8(N)
Abdominal P P P P 2 P P P N P P P P 8(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P N P P P P 8(N)
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-681MVL
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P P P P P 8(N)
Trans-vaginal P P P P 2 P P P P P P P 8(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-712BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P 2 P P P N P
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric P P P P 2 P P P N P
Small Organ (Note 1)
Neonatal Cephalic P P P P 2 P P P P
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-745BTF
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P 2 P P P P P 7(N)
Intra-operative (Abdominal) P P P P 2 P P P P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) N N N N 2 N N N N N
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-745BTH
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P 2 P P P N P 7(N)
Intra-operative (Abdominal) P P P P 2 P P P P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P N P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-745BTV
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal P P P P 2 P P P N P
Intra-operative (Abdominal) P P P P 2 P P P P
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P N P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-781VT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P P P P P 6(N)
Trans-vaginal P P P P 2 P P P P P P P 6(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVT-781VTE
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P P P P P 6(N)
Trans-vaginal P P P P 2 P P P P P P P 6(N)
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PVL-715RST
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal P P P P 2 P P P N P P P 6(N)
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLI-1205BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) N N N N 2 N N N N N N N N N N N 6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) N N N N 2 N N N N N N N N N N 6
Musculo-skeletal (Superficial) N N N N 2 N N N N N N N N N N 6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel N N N N 2 N N N N N N N N N N 6
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLI-2004BX
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) N N N N 2 N N N N N N N N N 6
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) N N N N 2 N N N N N N N N N 6
Musculo-skeletal (Superficial) N N N N 2 N N N N N N N N N 6
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel N N N N 2 N N N N N N N N N
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLT-704SBT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P P P P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) P P P P 2 P P P P P P
Musculo-skeletal (Superficial) P P P P 2 P P P P P P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P P P P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLT-705BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P P P P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) P P P P 2 P P P P P P
Musculo-skeletal (Superficial) P P P P 2 P P P P P P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P P P N
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLT-1005BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P P P P P P P P 6(N)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) P P P P 2 P P P P P P P P P 6(N)
Musculo-skeletal (Superficial) P P P P 2 P P P P P P P P P 6(N)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P P P P P P P 6(N)
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PLT-1204BT
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1) P P P P 2 P P P P P P P
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional) P P P P 2 P P P P P P P
Musculo-skeletal (Superficial) P P P P 2 P P P P P P P
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P P P P 2 P P P P P P P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PET-508MA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) P P P P P 3 P P
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PET-512MD
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac) N N N N N 3 N N
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: N/A
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PET-805LA
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal N N N N 2 N N N 7(N)
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic P P P P 2 P P P P P
Pediatric
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                     

System: Aplio i900, i800, i700 V2.0

Transducer: PC-20M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P
Cardiac Pediatric P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
Toshiba America Medical Systems, Inc. 510(k) Premarket Notification
Aplio i900, i800, i700 V2.0 Diagnostic Ultrasound System
                                                    

System: Aplio i900, i800, i700 V2.0

Transducer: PC-50M
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application Mode of Operation
Specific Other [Note]
B
M
PWD
CWD
Color Doppler
Combined (Specify)
Precision Imaging
Apli Pure
Micro Pure
BEAM
Power
TDI
Elastography
SMI(ADF)
Shear wave
4D
(Volume color)
3D Color
STIC
STIC Color
Smart 3D
Fusion
Smart Navigation
2D WMT
(Tracks 3)

Ophthalmic
Fetal
Abdominal
Intra-operative (Abdominal)
Intra-operative (Neuro)
Laparoscopic
Pediatric N
Small Organ (Note 1)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal(Conventional)
Musculo-skeletal (Superficial)
Intravascular
Other (Specify)
Cardiac Adult P
Cardiac Pediatric P
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Other (Specify)
Peripheral vessel P
Other (Specify)

N = new indication; P = previously cleared by FDA; E = added under this appendix

Previous 510(k) of the transducers: K151451
Prescription Use Only (Per 21 CFR 801.109)

Note 1 Small organ includes thyroid, breast and testicle

Note 2 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD
Note 3 Combined mode includes B/M; B/PWD; BDF/PWD; BDF/MDF; BDF/MDF/PWD; 2D/CWD; BDF/CWD
Note 4 ATI
Note 5 Tissue Intensity Analysis
Note 6 Sensor3D
Note 7 CHI (Per FDA approved contrast agent prescribing information)
Note 8 Shadow Glass
 510(k) SUMMARY

1. SUBMITTER’S NAME:
Toshiba Medical Systems Corporation
1385 Shimoishigami
Otawara-shi, Tochigi-ken, Japan 324-8550

2. OFFICIAL CORRESPONDENT
Akinori Hatanaka

3. ESTABLISHMENT REGISTRATION:
9614698

4. CONTACT PERSON:
Orlando Tadeo, Jr.
Manager, Regulatory Affairs
Toshiba America Medical Systems, Inc
2441 Michelle Drive
Tustin, CA 92780
(714) 669-7459

5. Date Prepared:
September 16, 2016

6. TRADE NAME(S):
Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.0

7. COMMON NAME:
System, Diagnostic Ultrasound

8. DEVICE CLASSIFICATION:
Class II
Ultrasonic Pulsed Doppler Imaging System – Product Code: 90-IYN [per 21 CFR 892.1550]
Ultrasonic Pulsed Echo Imaging System – Product Code: 90-IYO [per 21 CFR 892.1560]
Diagnostic Ultrasonic Transducer – Product Code: 90-ITX [per 21 CFR 892.1570]

2441 Michelle Drive, Tustin, CA 92780 / 714.730.5000 / medical.toshiba.com

9. PREDICATE DEVICE:
Product Marketed by 510(k) Number Clearance Date

Aplio 500/400/300 Toshiba America K151451 July 7, 2015

Diagnostic Ultrasound System V6.0 Medical Systems
Vivid E9 Diagnostic Ultrasound GE Healthcare K131514 July 12, 2013
System

10. REASON FOR SUBMISSION:

New device

11. DEVICE DESCRIPTION:

The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-
AI700, V2.0 are mobile diagnostic ultrasound systems. These systems are Track 3 devices
that employ a wide array of probes including flat linear array, convex linear array, and
sector array with frequency ranges between approximately 2 MHz to 20 MHz.

12. INDICATIONS FOR USE:

The Diagnostic Ultrasound Systems Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-
AI800 and Aplio i700 Model TUS-AI700 are indicated for the visualization of structures, and
dynamic processes with the human body using ultrasound and to provide image information
for diagnosis in the following clinical applications: fetal, abdominal, intra-operative
(abdominal), pediatric, small organs, trans-vaginal, trans-rectal, neonatal cephalic, adult
cephalic, cardiac (both adult and pediatric), peripheral vascular, transesophageal, musculo-
skeletal (both conventional and superficial) and laparoscopic.

13. SUBSTANTIAL EQUIVALENCE:

This device is substantially equivalent to the Aplio 500/400/300 V6.0 Diagnostic Ultrasound
System, K151451, marketed by Toshiba America Medical Systems. The Aplio i900 Model
TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-AI700, V2.0 function in
a manner similar to and is intended for the same use as the predicate device. The subject
device is a compact diagnostic ultrasound system by implementing latest technologies.

Aplio 500/400/300 Aplio i900/i800/i700 Comment

V6.0 V2.0
510(K) Control Number K151451 N/A (Subject Device)
Sensor 3D No Yes New feature
Shadow Glass No Yes New feature
Attenuation Imaging No Yes New feature
Shear Wave Dispersion No Yes New feature
(SWD)
Tissue Intensity Analysis No Yes New feature
(Normalized Local Variance
(NLV)/Ratio)
CHI (Contrast Harmonic No Yes New feature
Imaging) for Liver
 Aplio 500/400/300 Aplio i900/i800/i700 Comment
V6.0 V2.0
510(K) Control Number K151451 N/A (Subject Device)
Auto Volume Measurement No Yes New feature
Fusion Auto Track No Yes New feature
PSI-30BX transducer No Yes New transducer
PSI-70BT transducer No Yes New transducer
PVI-475BT transducer No Yes New transducer
PVI-475BX transducer No Yes New transducer
PLI-1205BX transducer No Yes New transducer
PLI-2004BX transducer No Yes New transducer

Vivid E9 Diagnostic Aplio i900/i800/i700 Comment

Ultrasound System V2.0
510(K) Control Number K131514 N/A (Subject Device)
Sensor 3D Yes Yes New feature
-Measurements (Tru3D(G))
Distance/Angle/Area/Volume
Registration with OmniTRAX Yes Yes New feature
Active Patient Tracker (CIVCO (Fusion Auto Track) *CIVCO 510(k)
Medical Instruments Co., Inc) clearance
- CT image numbers
- MR image CT: K092619
MR: K143396

Previously cleared features being implemented to the subject device:

Feature 510(k) Clearance Comments
Previously cleared under
Shear Wave Elastography No change to basic function
K151451
Previously cleared under
Elastography No change to basic function
K151451
Previously cleared under
SMI No change to basic function
K151451
Previously cleared under
Smart Fusion No change to basic function
K151451
Previously cleared under
Smart Navigation No change to basic function
K151451
Previously cleared under
Auto-NT No change to basic function
K151451
MultiCast Beam Former Previously cleared under Improvement to basic function
K140729 (Histogram)
Tissue Intensity Analysis Previously cleared under Improvement to basic function
(Ratio) K991710 (Multiple focus)
14. SAFETY:
The device is designed and manufactured under the Quality System Regulations as
outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the
applicable parts of the IEC60601-1 (2005), IEC 60601-2-37 (2007), IEC 62304 (2006),
AIUM RTD2-2004 Output Display and ISO 10993-1 standards.

15. TESTING
Risk Analysis, Verification/Validation testing conducted through bench testing which are
included in this submission demonstrates that the requirements for the features have
been met.

Performance Testing – Bench

Various phantom studies were conducted to demonstrate that the new features and
improvements to previously cleared features being implemented to the subject device
performed as intended. The studies concluded the following:

- Sensor 3D provides the expected 3D images of phantom structures, measurement

accuracy, hardness information and the frequency dispersion of the target of the 3D
image with the shear wave function
- Accurate quantitative attenuation coefficient results can be obtained using Attenuation
Imaging and that a color map is displayed to show the spatial distribution of attenuation
coefficient
- NLV can be used to visualize the distribution of homogeneous and heterogeneous
areas of various phantoms by displaying a color map
- Fusion Auto Track enables automatic fusion of real-time ultrasound images to previously
acquired CT or MR data sets by using the OmniTRAX Active Patient Tracker
- Auto Volume Measurement improves workflow using volume transducers compared with
the predicate device and that the measurement accuracy is within the specified range
- CHI can visualize the nonlinear signal including 2nd harmonic from the Contrast medium,
the quantification of the peak intensity, the time to reach the peak intensity
- Shear Wave Dispersion (SWD) can visualize a frequency dependency of the shear wave
speed (Phase velocity)
- Shadow Glass displays tissue and tissue with flow in a transparent manner

Performance Testing – Clinical Images

Clinical evaluations were conducted to demonstrate that the subject device performed as
expected. In one study representative clinical images of volunteer livers were obtained
and it was confirmed that Attenuation Imaging can display a color map of attenuation
coefficient as well as numerical results in-vivo. In another study representative clinical
images of volunteer livers were obtained and using NLV, the study confirmed that NLV
displays acceptable color map images and mean NLV values, in-vivo.

Software Documentation for a Moderate Level of Concern, per the FDA guidance
document, “Guidance for the Content of Premarket Submissions for Software Contained
in Medical Devices Document” issued on May 11, 2005, is also included as part of this
submission.
 Additionally, testing of this device was conducted in accordance with the applicable
standards published by the International Electrotechnical Commission (IEC) for Medical
Devices.

16. CONCLUSION
The Aplio i900 Model TUS-AI900, Aplio i800 Model TUS-AI800 and Aplio i700 Model TUS-
AI700, V2.0 is substantially equivalent to the predicate devices. The subject devices
function in a manner similar to and is intended for the same use as the predicate devices,
as described in the labeling. Based upon the bench testing, acquisition of representative
clinical images, successful completion of software validation, application of risk
management and design controls, it is concluded that this device is safe and effective for its
intended use.