Shenzhen Mindray Bio-medical Electronics Co.

, LTD June 10, 2021

℅ Hao Yixuan
Engineer of Technical Regulation
Mindray Building, Keji 12th Road South, Hi-tech Industrial Park
Nanshan, Shenzhen 518057
P.R. CHINA

Re: K210699
Trade/Device Name: Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona
I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9,
Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9,
Anesus I9 Easi, Eagus I9 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: May 24, 2021
Received: May 27, 2021

Dear Hao Yixuan:

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. 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
located 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.

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

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.04.26
Silver Spring, MD 20993
www.fda.gov
K210699 - Hao Yixuan Page 2

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 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR
803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.

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 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 ([email protected]) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and 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)

K210699
Device Name
Resona I9/Resona I9 Exp/Resona I9S/Resona I9T/Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9/Imagyn I9S/Imagyn I9 Easi/
Nuewa I9/Nuewa I9S/ Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9/Anesus I9 Easi/Eagus I9 Diagnostic Ultrasound System

Indications for Use (Describe)

Resona I9/Resona I9 Exp/Resona I9S/Resona I9T/Resona I9 Easi/Resona I9 Nasa/Resona IV/Imagyn I9/Imagyn I9S/
Imagyn I9 Easi/Nuewa I9/Nuewa I9S/ Nuewa I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9/Anesus I9 Easi/Eagus I9
Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for
use in fetal, abdominal, pediatric, small organ (breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-
vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel,
urology and Thoracic/Pleural 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).

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.*
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
[email protected]
“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 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

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 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: K210699

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
Hao Yixuan
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: February 28, 2021

2. Device Name
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,
Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa
I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 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 I9 series Diagnostic Ultrasound System is comparable with and substantially
equivalent to the predicate devices listed below. Resona 7 is the main predicate devices.

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 Device Manufacturer Model Device Product 510K
Class Code Number
1. Main predicate II IYN, IYO, ITX
Mindray Resona 7 K171233
device
II IYN, IYO, ITX，
2. Reference device Mindray DC-80 K192152
LLZ
3. Reference device Mindray MX7 II IYN, IYO, ITX K200001
4. Reference device Mindray ZS3 II IYN, IYO, ITX K192410
5. Reference device Samsung RS85 II IYN, IYO, ITX K192903
6. Reference device SuperSonic Aixplorer II IYN, IYO, ITX K173021
7. Reference device GE LOGIQ E9 II IYN, IYO, ITX K163077
VOLUS II IYN, IYO, ITX
8. Reference device GE K181985
ON E8

The result shows the conformance of subject device to the predicate devices.
Regulation name and code
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)
21 CFR 892.2050 Picture Archiving and Communications System
(LLZ)

4. Device Description:
The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona
I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa
I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi,
Eagus I9 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 I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona
I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa
I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi,
Eagus I9 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.

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5. Intended Use:
Resona I9/Resona I9 Exp/Resona I9S/Resona I9T/Resona I9 Easi/Resona I9 Nasa/
Resona IV/Imagyn I9/Imagyn I9S/Imagyn I9 Easi/Nuewa I9/Nuewa I9S/Nuewa
I9T/Nuewa I9 Exp/Nuewa I9 Easi/Anesus I9/Anesus I9 Easi/Eagus I9 Diagnostic
Ultrasound System is applicable for adults, pregnant women, pediatric patients and
neonates. It is intended for use in fetal, abdominal, pediatric, small organ (breast,
thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-
skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph.
(Cardiac), peripheral vessel, urology and Thoracic/Pleural 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).

6. Comparison with Predicate Devices:

Subject device Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi,
Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9,
Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi,
Eagus I9 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 I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9
Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi,
Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9,
Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System has the same intended
uses as the predicated device Resona 7 (K171233) except the thoracic/pleural
exam, which has been cleared on predicate device MX7(K200001) and the
imaging modes as the predicated devices.

007-3
 The patient contact materials of the transducers and needle-guided brackets of
subject device Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9
Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi,
Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9,
Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System are the same to the
predicate devices or tested under ISO 10993-1.
 The acoustic power levels of Resona I9, Resona I9 Exp, Resona I9S, Resona
I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S,
Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9
Easi, Anesus I9, Anesus I9 Easi, Eagus I9 are below the limits of FDA, which
are the same as the predicated device Resona 7 (K171233).
 Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9
Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa
I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi,
Eagus I9 is designed in compliance with the FDA recognized electrical and
physical safety standards, which are the same as the predicated device Resona 7
(K171233).
 The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi,
Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9,
Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9
Easi, Eagus I9 has the equivalent features and functions as the predicated
devices.
For the differences compared to the predicate devices:
 The Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi,
Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9,
Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9
Easi, Eagus I9 introduces new software and hardware options which in the
below table that used as improvements or enhancement based on the cleared
functions to facilitate users, no new intended use are added and all of them have
passed the related tests, no clinical risks have been recognized nor introduced.
High frame rate STE function is used to improve the
High frame rate
frame rate (FR) for STE. High frame rate STE is a High
STE
frame rate mode of STE
In 3D/4D acquisition preparation status, this feature can
adjust ROI size and position automatically and activate
Smart Scene 3D
appropriate render modes according to the recognized
anatomical structure of some organs.
Measures the pixel proportion of blood flow signal in the

CPP region of interest under Color or Power mode. The feature

is not supported under TDI mode.

007-4
 DICOM basic unit installed first.
DICOM Small Purpose: The ultrasound system transfers the
Parts SR measurements obtained from Small Parts studies to
storage devices.
There are two kinds of standby battery assemblies, 4 sets
Battery assembly
and 8 sets of batteries.
This optional hardware should be installed to realize the
iClear+ Dongle
iClear+ function
The probe adapter is used for probe-unit interface
conversion. PCM-US01 Probe Adapter is used for probes
with U-type socket to connect to the main unit with S-type
Probe Adapter socket accepted interface. The P7-3TU or SP5-1U probe
PCM-ES01 and should be configured.
PCM-US01 PCM-ES01 Probe Adapter is used for probes with E-type
socket to connect to the main unit with S-type socket
accepted interface. The SD8-1E, P7-3TE, SC6-1E, or
SP5-1E probe should be configured.
Magnetic
navigation Used for carrying the magnetic navigation controller.
controller box

7. Non-clinical Tests:
Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa,
Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa
I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 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.
 AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, c1:2009/(r)2012 and
a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1:
general requirements for basic safety and essential performance (iec 60601-
1:2005, mod).
 IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential performance - Collateral
Standard: Electromagnetic disturbances - Requirements and tests
 IEC 60601-1-6 Edition 3.1 2013-10, medical electrical equipment - part 1-6:

007-5
 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 Second edition 2007-03-01, 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 1.0 2015-02 Medical devices - Part 1: Application of usability
engineering to medical devices [Including CORRIGENDUM 1 (2016)].

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 I9, Resona I9 Exp, Resona I9S,
Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S,
Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi,
Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System, does not
require clinical studies to support substantial equivalence.

9. Summary
Based on the performance data as documented in the study, the Resona I9,
Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV,
Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa
I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 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 I9, Resona I9 Exp, Resona I9S,
Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S,

007-6
Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi,
Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System is
substantially equivalent with respect to safety and effectiveness to its primary
predicate device Resona 7.

007-7