Resona R9/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9/Nuewa R9 Pro/Nuewa R9 Pro/Nuewa R9S/Resona 7/ Resona 7CV/Resona 7EXP/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant woments and neonates. If is intended for use in fetal, abdominal. Intraoperative, pediatic, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, musculoskeletal(conventional, superficial), adult and pediatic cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.

This device is a general purpose diamostic ultrasound system intended for use by qualified and trained healtheare 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.

Modes of operation include: B, M, PWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart 3D, 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).

Device Description

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system.

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

AI/ML Overview

The provided document is a 510(k) Summary for a Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and performance data for a new AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics (especially for AI/CADe tools) is not present in this document.

However, I can extract information related to the device's broader regulatory and non-clinical testing.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the document as a set of quantified acceptance criteria and corresponding performance metrics for a specific function or feature. The document extensively compares the device to predicate devices and lists various non-clinical tests performed, implying that meeting standards is the "acceptance criteria."

However, I can infer the "acceptance criteria" based on the listed non-clinical tests and the "performance" as compliance with these standards and equivalence to predicate devices.

Acceptance Criteria (Inferred)	Reported Device Performance
Acoustic Output: Below FDA limits (NEMA UD 2-2004 (R2009))	"The acoustic power levels of [Device Names] are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)." (Page 9)
Electrical and Physical Safety: Compliance with AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-6 Ed. 3.1, IEC 60601-2-37 Ed. 2.1	"Resona R9...is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)." (Page 9)
Biocompatibility: Transducer materials tested under ISO 10993-1. Specific testing for ELC13-4U transducer.	"The patient contact materials of the transducers are tested under ISO 10993-1." (Page 9) "The materials used in the new transducers (except for ELC13-4U) and needle-guided brackets were the same as in the predicate device. And the ELC13-4U transducer was testing for biocompatibility." (Page 5)
Cleaning and Disinfection Effectiveness: Provided instructions for end-user.	"All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual." (Page 5)
Risk Management: Compliance with ISO 14971	"This device has been tested and evaluated under the following standards: ...ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices." (Page 11)
Software Life Cycle Processes: Compliance with AAMI / ANSI / IEC 62304:2015	"This device has been tested and evaluated under the following standards: ...AAMI / ANSI / IEC 62304:2015, medical device software - software life cycle processes." (Page 11)
Usability Engineering: Compliance with IEC 62366-1 Edition 1.0 2015-02	"This device has been tested and evaluated under the following standards: ...IEC 62366-1 Edition 1.0 2015-02 medical devices - application of usability engineering to medical devices." (Page 11)
Overall Safety and Effectiveness Profile: Similar to predicate device.	"Based on the performance data as documented in the study, the Resona R9 series Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device." (Page 12) "The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems." (Page 12)
Functional Equivalence: Same intended uses, basic operating modes, technological characteristics, imaging modes, and comparable key safety and effectiveness features as predicate devices (e.g., Resona 7 (K171233), DC-80 (K192152), RS85 (K192903), etc., for specific features like AutoEF, Ultra-Micro Angiography, Smart Fetal HR). Transducers are similar or cleared. New features are comparable to features in other cleared predicate/reference devices.	"Resona R9...has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes." (Page 8) "The subject device also has the same intended uses and basic operating modes as the predicate devices." (Page 8) "The Resona R9...has the same imaging modes as the predicated devices." (Page 10) "The Resona R9...has the same functions as the predicated devices." (Page 10) "The Resona R9...has similar tranducers with the predicated devices." (Page 10)

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This document does not describe a clinical study with a test set of patient data. The evaluation is based on non-clinical engineering and performance testing against recognized standards and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No human expert ground truth was established for a test set, as no clinical study is presented.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or ground truth was established that would require adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable/Not provided. This document explicitly states: "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." (Page 11). Therefore, no MRMC study was conducted or reported. The device is a diagnostic ultrasound system, not specifically an AI/CADe tool for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable/Not provided. The document does not describe a standalone algorithm performance evaluation. Some features listed (e.g., Smart V Trace, Smart ICV, AutoEF, Smart Fetal HR, Smart Caliper, Smart Trace) imply quantitative analysis capabilities, but no performance metrics for these "smart" features are provided in a standalone context. These are likely integrated functions within the ultrasound system, not standalone AI algorithms intended for independent evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not provided. For the non-clinical tests conducted, the "ground truth" would be the specifications and requirements of the referenced standards (e.g., NEMA UD 2, IEC 60601 series, ISO 10993-1).

8. The sample size for the training set

Not applicable/Not provided. This document describes a traditional medical device (ultrasound system) and its non-clinical testing for substantial equivalence, not the development or training of an AI/ML algorithm. Therefore, no training set information is provided.

9. How the ground truth for the training set was established

Not applicable/Not provided. As no training set is discussed, there's no information on how its ground truth might have been established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

Shenzhen Mindray Bio-Medical Electronics Co., LTD % Ma Chao Engineer of Technical Regulation Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057 P.R. CHINA

Re: K202785

Trade/Device Name: Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9, Nuewa R9, Nuewa R9 Exp. Nuewa R9 Pro. Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y 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: December 1, 2020 Received: March 8, 2021

April 8, 2021

Dear Ma Chao:

We have reviewed vour 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

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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 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-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Michael D. O'Hara

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 Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K202785

Device Name

Resona R9 Exp/Resona R9 Exp/Resona R9S/Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S/Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System

Indications for Use (Describe)

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)

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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: K202785

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 6573 Fax: +86 755 2658 2680

Contact Person:

Ma Chao 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: April 05, 2021

2. Device Name:

Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y 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 R9 series Diagnostic Ultrasound System is substantially equivalent in its

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main predicate devices.
Device	Manufacturer	Model	Device Class	Product Code	510(k) Number
1. Main predicate device	Mindray	Resona 7	II	IYN, IYO, ITX	K171233
2. Reference device	Mindray	DC-80	II	IYN, IYO, ITX, LLZ	K192152
3. Reference device	Mindray	M6	II	IYN, IYO, ITX	K171579
4. Reference device	Mindray	MX7	II	IYN, IYO, ITX	K200001
5. Reference device	Mindray	M9	II	IYN, IYO, ITX	K171034
6. Reference device	Samsung	RS85	II	IYN, IYO, ITX	K192903
7. Reference device	Easote S.P.A	MylabTwice	II	IYN, IYO, ITX	K163082
8. Reference device	Philips	EPIQ 7	II	IYN, IYO, ITX	K182857
9. Reference device	SuperSonic	Aixplorer	II	IYN, IYO, ITX	K173021
10. Reference device	GE	LOGIQ E9	II	IYN, IYO, ITX	K163077
11. Reference device	GE	VOLUSON E8	II	IYN, IYO, ITX	K181985
12. Reference device	Mindray	TE7	II	IYN, IYO, ITX	K143472
13. Reference device	Mindray	DC-80A	II	IYN, IYO, ITX	K201693

technologies and functionality to Resona 7 Diagnostic Ultrasound System (predicate devices) that are already cleared by FDA, and they are listed below. Resona 7 is the dicate der

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:

This system is a Track 3 device that employs an array of probes that include linear array, Phased array, pencil phased and convex array.

The safety and effectiveness of the new transducers is equivalent with predicate devices. And the 7LT4s, P8-3Ts has been cleared in FDA.

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The materials used in the new transducers (except for ELC13-4U) and needle-guided brackets were the same as in the predicate device. And the ELC13-4U transducer was testing for biocompatibility.

All the transducers and needle-guided brackets were provided non-sterile to the end user. And all the disinfection/sterilization methods for the new transducers and needle guide brackets were provided to the end user and the users are notified that disinfection /sterilizaiton are necessary in the Operation Manual.

5. Intended Use:

Resona R9/Resona R9 Exp/Resona R9 Pro/Resona R9S/Nuewa R9/Nuewa R9 Exp/Nuewa R9 Pro/Nuewa R9S/Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B/Resona 7PRO/Imagyn 7/Resona Y Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, Intra-operative, pediatric, small organ(breast, thyroid, neonatal adult adult cephalic. trans-rectal. testes). trans-vaginal. musculo-skeletal(conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel,urology exams.

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.

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, Smart 3D, 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. Summary of Modifications and New Added Features

This submission device is a modification to Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System previously cleared in 171233.

No.	New features
1.	Add new models Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, NuewaR9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7PRO, Imagyn 7, Resona Y
2.	Add new transducers ELC13-4U, L14-3WU, DL14-3U, C6-2Gs, 7LT4s, P8-3Ts, L13-3WU andneedle-guided bracket NGB-010, NGB-029, NGB-035, NGB-042, NGB-051, NGB-054
3.	Cancel transducers DE11-3U and needle-guided bracket NGB-027
4.	Add Urology clinical application to Convex transducers C5-1U, C6-2GU, DE10-3U, DE10-3WU,SC5-1U and SC6-1U
5.	Add Peripheral vessel and Urology clinical application to Convex transducers SC8-2U and C4-1U
6.	Add Abdominal clinical application to Linear transducers L20-5U
7.	Add Pediatric and Neonatal Cephalic clinical application to Phased transducers P10-4U
8.	Add Peripheral vessel clinical application to CW transducers CW5s
9.	Add CWD to transducers L14-5WU and L20-5U
10.	Add Biopsy Guidance to transducers D8-4U and L14-5WU
11.	Add Contrast imaging (Contrast agent for Liver) function to transducers SC8-2U, L11-3U, L9-3U,L14-5WU and C11-3U
12.	Add Strain Elastography function to transducers L20-5U (Small Organ), L14-5WU (Peripheralvessel), L16-4HU, L16-4Hs and DE10-3WU
13.	Add STE function to transducers L9-3U, V11-3HU, L20-5U, L14-5WU (Peripheral vessel),C6-2GU, C4-1U and DE10-3WU
14.	Add STQ function to transducers L9-3U, L20-5U, L14-5WU, C6-2GU, and C4-1U
15.	Add Ultrasound Fusion Imaging function to transducers V11-3HU and C6-2GU
16.	Add Needle Navigation function to transducers C5-1U, SC8-2U, SP5-1U, C6-2GU and C4-1U
17.	New Added Features	HiFR CEUS
18.		Endocavity STE
19.		High frame rate STE
20.		Smart V Trace
21.		Smart ICV
22.		Smart Scene 3D
23.		Endocavity Fusion Imaging
24.		AutoEF
25.		Glazing Flow
26.		Ultra-Micro Angiography
27.	Smart Fetal HR
28.	iClear+
29.	Smart Hip
30.	Smart HRI
31.	Smart Caliper
32.	Smart Trace
33.	McAfee
34.	V access
35.	CPP
36.	DICOM Small Parts SR
37.	Battery

The new features:

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7. Comparison with Predicate Devices:

The modified Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Device	Manufacturer	Model	510(k)Number
1. Main predicate device	Mindray	Resona 7	K171233
2. Reference device	Mindray	DC-80	K192152
3. Reference device	Mindray	M6	K171579
4. Reference device	Mindray	MX7	K200001
5. Reference device	Mindray	M9	K171034
6. Reference device	Samsung	RS85	K192903
7. Reference device	Easote S.P.A	MylabTwice	K163082
8. Reference device	Philips	EPIQ 7	K182857
9. Reference device	Supersonic	Aixplorer	K173021

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10. Reference device	GE	LOGIQ E9	K163077
11. Reference device	GE	VOLUSONE8	K181985
12. Reference device	Mindray	TE7	K143472
13. Reference device	Mindray	DC-80A	K201693

. Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y has the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes. 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, and calculations. The subject device also has the same intended uses and basic operating modes as the predicate devices
Subject device Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y has the same intended uses as the predicated device Resona 7 (K171233).

Items	Subject DeviceResona R9 series	Predicate deviceResona 7(K171233)	S/D
Indicationsfor use	Resona R9/Resona R9 Exp/ResonaR9 Pro/Resona R9S/NuewaR9/Nuewa R9 Exp/Nuewa R9Pro/Nuewa R9S/Resona 7/Resona7CV/Resona 7EXP/Resona7S/Resona 7OB/Resona7PRO/Imagyn 7/Resona YDiagnostic Ultrasound System isapplicable for adults, pregnantwomen, pediatric patients andneonates. It is intended for use infetal, abdominal, Intra-operative,pediatric, small organ (breast,thyroid, testes), neonatal and adultcephalic, trans-rectal, trans-vaginal,	The Resona 7/Resona 7CV/Resona7EXP/Resona 7S/Resona 7OBdiagnostic ultrasound system isapplicable for adults, pregnantwomen, pediatric patients andneonates. It is intended for use infetal, abdominal, Intra-operative,pediatric, small organ (breast,thyroid, testes), neonatal and adultcephalic, trans-rectal, trans-vaginal,musculo-skeletal (conventional,superficial), adult and pediatriccardiac, trans-esoph. (Cardiac),peripheral vessel, urology exams.	S

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musculo-skeletal (conventional, superficial), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, urology exams.	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.
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.	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, Smart 3D, 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).
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, Smart 3D, 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 patient contact materials of the transducers are tested under ISO 10993-1. ●
The acoustic power levels of Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233).
Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y 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 R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y has the

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same imaging modes as the predicated devices.

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y has the same functions as the predicated devices.

Functions	Predicated devices
Endocavity STE	SE12-3&Aixplorer(K173021)
Smart V Trace	Voluson E8(K181985)
Smart ICV	Voluson E8(K181985)
Endocavity Fusion Imaging	IC5-9-D&LOGIQ E9(K163077)
AutoEF	DC-80(K192152)
Glazing Flow	DC-80(K192152)
Ultra-Micro Angiography	RS85 (K192903)
Smart Fetal HR	Resona 7(K171233)
iClear+	Resona 7(K171233)
Smart Hip	Resona 7(K171233)
Smart HRI	RS85 (K192903)
Smart Caliper	Resona 7(K171233)
Smart Trace	Resona 7(K171233)
V access	M9(K171034)

The Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y has similar tranducers with the predicated devices.

Subject Device Resona R9	Reference device
ELC13-4U_L	6LB7E_L&DC-80(K192152)
ELC13-4U_C	6LB7E_C&DC-80(K192152)
L14-3WU	L11-3U&Resona 7(K171233)
L13-3WU	L11-3U&Resona 7(K171233)
DL14-3U	VL13-5&EPIQ 7(K182857)
C6-2Gs	C6-2GU&Resona 7(K171233)
	C5-1s&MX7(K200001)
7LT4s	7LT4s&M6(K171579)
P8-3Ts	P8-3Ts&M9(K171034)

8. Non-clinical Tests:

Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9

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Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 70B, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and 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: 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.
AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices - part 1: evaluation and testing within a risk management process.
AAMI / ANSI / IEC 62304:2015, medical device software - software life cycle processes.
IEC 62366-1 Edition 1.0 2015-02 medical devices - 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.

9. Clinical Studies

Not applicable. The subject of this submission, Resona R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System, does not require clinical studies to support substantial equivalence.

10. Summary

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Based on the performance data as documented in the study, the Resona R9 series Diagnostic Ultrasound system was found to have a safety and effectiveness profile that is similar to the predicate device.

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 R9, Resona R9 Exp, Resona R9 Pro, Resona R9S, Nuewa R9, Nuewa R9 Exp, Nuewa R9 Pro, Nuewa R9S, Resona 7, Resona 7CV, Resona 7EXP, Resona 7S, Resona 7OB, Resona 7PRO, Imagyn 7, Resona Y Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.