Shenzhen Mindray Bio-medical Electronics Co., LTD.
April 22, 2024
℅ Tang Jing
Technical manager Regulatory Affairs, Technical Regulation Department
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen, Guangdong 518057
CHINA
Re: K240115
Trade/Device Name: Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona
I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa
I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic
Ultrasound System
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic Pulsed Doppler Imaging System
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: March 21, 2024
Received: March 22, 2024
Dear Tang Jing:
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 (the 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.
Although this letter refers to your product as a device, please be aware that some cleared products may instead be
combination products. The 510(k) Premarket Notification Database available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA
guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.06.09
Silver Spring, MD 20993
www.fda.gov
K240115 - Tang Jing Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to
an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820),
which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product;
and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires
premarket review, the QS regulation requires device manufacturers to review and approve changes to device
design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device
master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing
safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-
products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for
devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-
1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97).
For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go
to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-
medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-
advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-
education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE)
to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-
education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041
or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D.
Assistant Director
Mammography and Ultrasound Team
DHT8C: Division of Radiological Imaging
and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
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: 06/30/2023
Indications for Use See PRA Statement below.
510(k) Number (if known)
K240115
Device Name
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8,
Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound
System
Indications for Use (Describe)
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W,
Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for
use in fetal, abdominal, Intra-operative (includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ
(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional,
superficial), Thoracic/Pleural, adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B,
Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape
View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ, Contrast
imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare
professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended
to be used in a hospital or medical clinic.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.*
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information unless it displays a currently valid OMB number.”
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
K240115
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in
accordance with the requirements of SMDA 1990 and 21 CFR § 807.92(c).
The assigned 510(k) number: K240115
1. Submitter
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan,
Shenzhen, 518057, P. R. China
Tel: +86 755 8188 6129
Fax: +86 755 2658 2680
Contact Person
Tang Jing
Shenzhen Mindray Bio-medical Electronics Co., LTD
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park,
Nanshan, Shenzhen, 518057, P. R. China
Date Prepared: January 8, 2024
2. Device Name
Resona I8WResona I8Resona I8 ExpResona I8SResona I8TResona IY,
Resona I8 EasiEagus I8 EasiNuewa I8WNuewa I8Nuewa I8 ExpNuewa
I8SNuewa I8TImagyn I8Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System
Classification
Regulatory Class: II
Review Category: Tier II
21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
3. Predicate devices
Resona I8W series Diagnostic Ultrasound System is comparable with and
substantially equivalent to the predicate devices listed below. Resona I9 is the main
1
predicate devices.
Device 510K
Device Manufacturer Model Product Code
Class Number
1. Main predicate device Mindray Resona I9 II IYN, IYO, ITX K210699
2. Reference device Mindray Resona R9 II IYN, IYO, ITX K222928
3. Reference device Mindray MX7 II IYN, IYO, ITX K212900
4. Reference device Mindray TEX20 II IYN, IYO, ITX K220242
5. Reference device Mindray TE7 II IYN, IYO, ITX K203391
6. Reference device Mindray DC-80A II IYN, IYO, ITX K201693
7. Reference device Mindray ZS3 II IYN, IYO, ITX K192410
8. Reference device Mindray Consona N9 II IYN, IYO, ITX K221300
9. Reference device Mindray Voluson E10 II IYN, IYO, ITX K181985
The result shows the conformance of subject device to the predicate devices.
Regulation name and code
21 CFR 892.1550 Ultrasonic Pulsed Dopple Imaging System
(IYN)
21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (IYO)
21 CFR 892.1570 Diagnostic Ultrasound Transducer (ITX)
4. Device Description:
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S,
Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY
Diagnostic Ultrasound System is a general purpose, mobile, software controlled,
ultrasonic diagnostic system. Its function is to acquire and display ultrasound
images in Modes of operation include: B, M, PWD, CWD , Color Doppler,
Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B,
PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, 4D(Real-
time 3D), iScape View, TDI, Color M, Strain Elastography, Contrast imaging
(Contrast agent for LVO), V Flow, STE, STQ, Contrast imaging (Contrast agent
for Liver).
The Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S,
Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY
Diagnostic Ultrasound System can also measure anatomical structures and offer
analysis packages to provide information based on which the competent health
care professionals can make the diagnosis.
2
5. Indications for Use:
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona
I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa
I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic
Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates. It is intended for use in fetal, abdominal, Intra-operative
(includes abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ
(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal,
musculo-skeletal (conventional, superficial), Thoracic/Pleural, adult and pediatric
cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler,
Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B),
Tissue Harmonic Imaging, Smart3D, 4D(Real-time 3D), iScape View, TDI, Color M,
Strain Elastography, Contrast imaging (Contrast agent for LVO), V Flow, STE, STQ,
Contrast imaging (Contrast agent for Liver).
This device is a general purpose diagnostic ultrasound system intended for use by
qualified and trained healthcare professionals for ultrasound imaging, measurement,
display and analysis of the human body and fluid, which is intended to be used in a
hospital or medical clinic.
6. Comparison with Predicate Devices:
Subject device Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T,
Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp,
Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System is comparable with and substantially equivalent to
these predicate devices mentioned in 3. Predicate Devices with regards to intended use,
imaging modes, features and functions and technological characteristics.
All systems transmit ultrasonic energy into patients, perform post processing of
received echoes to generate onscreen display of anatomic structures and fluid
flow within the body. All systems allow for specialized measurements of
structures and flow, as well as calculations.
Subject device Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T,
Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8
Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8
Exp, Nuewa IY Diagnostic Ultrasound System has the same intended uses as the
predicated device Resona I9 (K210699).
3
The patient contact materials of the transducers and needle-guided brackets of
subject device Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T,
Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp,
Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp,
Nuewa IY Diagnostic Ultrasound System are the same to the predicate devices.
The acoustic power levels of Resona I8W, Resona I8, Resona I8 Exp, Resona
I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa
I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T,
Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System are below the limits
of FDA, which are the same as the predicated device Resona I9 (K210699).
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa
I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System is designed in compliance with the FDA
recognized electrical and physical safety standards, which are the same as the
predicated device Resona I9 (K210699).
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa
I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System has the equivalent features and functions as
the predicated devices. Among these features, the USAT, HRI+, HiFR CEUS,
CEUS Chrono-Parametric Mode, TCMR, 3D-Print Format, Ultra-Micro
Angiography, DICOM Pediatric SR, DICOM Urology SR and Biopsy Grid
supported in proposed Resona I8W series has been cleared in predicate device
Resona R9(K222928).
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa
I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System has the equivalent features and functions as
the predicated devices. Among these features, the Smart Bladder and ClamAV
supported in proposed Resona I8W series has been cleared in predicate device
Consona N9 (K221300).
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,
Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa
I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa
IY Diagnostic Ultrasound System has the equivalent features and functions as
the predicated devices. Among these features, the IOTA supported in proposed
Resona I8W series has been cleared in predicate device Voluson E10 (K181985).
7. Non-clinical Tests:
Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona
4
I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa
I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic
Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning
and disinfection effectiveness as well as thermal, electrical and mechanical safety, and
this device has been designed to conform with applicable medical safety standards.
This device has been tested and evaluated under the following standards:
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic
ultrasound equipment revision 3.
ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] Medical electrical equipment
- Part 1: General requirements for basic safety and essential performance (IEC
60601-1:2005, MOD) [Including Amendment 2 (2021)]
IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, Medical
electrical equipment - Part 1-2: General requirements for basic safety and
essential performance - Collateral Standard: Electromagnetic disturbances -
Requirements and tests.
IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2:
Guidance and interpretation - Electromagnetic immunity: performance of
medical electrical equipment and medical electrical systems
IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, Medical
electrical equipment - Part 1-6: General requirements for basic safety and
essential performance - Collateral standard: Usability.
IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential performance of
ultrasonic medical diagnostic and monitoring equipment.
ISO 14971 Third Edition 2019-12, Medical devices - Application of risk
management to medical devices.
ISO 10993-1 Fifth edition 2018-08, biological evaluation of medical devices -
part 1: evaluation and testing within a risk management process.
IEC 62304 Edition 1.1 2015-06, medical device software - software life cycle
processes.
IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Medical devices -
Part 1: Application of usability engineering to medical devices.
These non-clinical tests relied on in this premarket notification submission can
support the determination of substantial equivalence of the subject device.
8. Clinical Studies
Not applicable. The subject of this submission, Resona I8W, Resona I8, Resona I8 Exp,
5
Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W,
Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn
I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System, does not require
clinical studies to support substantial equivalence.
9. Summary
Based on the performance data as documented in the study, Resona I8W, Resona
I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi,
Nuewa I8W, Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn
I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System was found
to have a safety and effectiveness profile that is similar to the predicate device.
10.Conclusion:
Intended uses and other key features are consistent with traditional clinical practices,
FDA guidelines and established methods of patient examination. The design,
development and quality process of the manufacturer confirms with 21 CFR 820, ISO
9001 and ISO 13485 quality systems. The device conforms to applicable medical
device safety standards. Therefore, the Resona I8W, Resona I8, Resona I8 Exp,
Resona I8S, Resona I8T, Resona IY, Resona I8 Easi, Eagus I8 Easi, Nuewa I8W,
Nuewa I8, Nuewa I8 Exp, Nuewa I8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn
I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System is substantially
equivalent with respect to safety and effectiveness to the predicate device Resona I9.
