The Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 6/Resona 5/Resona 57/ Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.

Device Description

The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color). This system is a Track 3 device that employs an array of probes that include linear array. Phased array and convex array.

AI/ML Overview

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Resona 6/Resona diagnostic ultrasound system. It indicates that the device has been evaluated through non-clinical testing to demonstrate substantial equivalence to predicate devices, and no clinical studies were deemed necessary or performed to support this submission.

Therefore, I cannot provide details on acceptance criteria and a study that proves the device meets those criteria from the given text, as no such clinical study was conducted. The information provided heavily emphasizes non-clinical testing and comparison to predicate devices, which is typical for 510(k) submissions demonstrating substantial equivalence rather than novel device performance.

However, based on the information implicitly stating that non-clinical tests were sufficient to demonstrate substantial equivalence to predicate devices, we can infer the "acceptance criteria" are compliance with established regulatory standards and the performance of the predicate device.

Here's an analysis of what would be relevant if a clinical study had been performed, and how the available information relates to the request:

Based on the provided document, no clinical study was conducted to prove the device meets specific acceptance criteria in a clinical setting. The submission relies on non-clinical tests and comparison to a legally marketed predicate device (Mindray Resona 7, K171233) to demonstrate substantial equivalence.

Therefore, the following points in your request cannot be directly answered from the provided text:

Table of acceptance criteria and reported device performance (from a clinical study): Not available. The document states "Non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device." The acceptance criteria are implicitly that the device performs equivalently to the predicate and meets safety standards, as demonstrated by non-clinical means.
Sample size used for the test set and data provenance: No clinical test set.
Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable as there was no clinical test set/ground truth established in a clinical setting.
Adjudication method for the test set: Not applicable.
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. This device is an ultrasound system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for clinical ground truth. For non-clinical testing, the "ground truth" would be the established performance metrics and safety standards.
The sample size for the training set: Not applicable as no AI/machine learning model is described.
How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding demonstration of equivalence (which serves as the basis for "acceptance"):

Acceptance Criteria (Implicit - based on Substantial Equivalence): The device is accepted if it is "substantially equivalent" to legally marketed predicate devices. This means it must:

Have the same intended uses.
Have the same technological characteristics, or if different, the differences do not raise new questions of safety and effectiveness and are demonstrated to be as safe and effective as the predicate.
Perform comparably in key safety and effectiveness features.

Reported Device Performance (as demonstrated through non-clinical testing and comparison to predicate):

The document states:

"Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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."
It has the "same intended uses" as the predicate device Resona 7 (K171233).
"The patient contact materials of the transducers are tested under ISO 10993-1."
"The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233)."
"designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K171233)."
"has the same imaging modes as the predicated devices."
"All of the functions... are the same as the predicated devices."
"has similar transducers with the predicated devices."

Summary of "Acceptance Criteria" and "Device Performance" as inferred from the 510(k) summary:

Acceptance Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (as per 510(k) Summary)
1. Same Intended Use as Predicate: Applicable for adults, pregnant women, pediatric patients, and neonates; for use in fetal, abdominal, pediatric, small organ, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.	The subject device has the "same intended uses and basic operating modes" as the predicate device Resona 7 (K171233). Specific applications listed match the predicate.
2. Same Technological Characteristics (or equivalent safety/effectiveness): Utilizing B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape, TDI, Color M, Strain Elastography, 3D/4D, Contrast imaging (Liver/LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ, and combined modes.	The subject device "has the same technological characteristics," "same imaging modes," "all of the functions... are the same," and "similar transducers" as the predicate devices.
3. Safety Standards Compliance:	"The acoustic power levels... are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233).""designed in compliance with the FDA recognized electrical and physical safety standards," specifically: - NEMA UD 2-2004 (R2009) (Acoustic Output)- AAMI/ANSI ES60601-1:2005/(R)2012 (Basic Safety & Essential Performance)- AAMI/ANSI/IEC 60601-1-2:2007/(R)2012 (EMC)- IEC 60601-1-6 Ed. 3.1 (Usability)- IEC 60601-2-37 Ed. 2.0 (Specific Ultrasound Safety)- ISO 14971 (Risk Management)- AAMI/ANSI/ISO 10993-1:2009/(R)2013 (Biocompatibility)- AAMI/ANSI/IEC 62304:2006 (Software Life Cycle)- AAMI/ANSI/IEC 62366:2007/(R)2013 (Usability Engineering)
4. Biocompatibility: Patient contact materials meet safety standards.	"The patient contact materials of the transducers are tested under ISO 10993-1."
5. Cleaning and Disinfection Effectiveness.	"evaluated for... cleaning and disinfection effectiveness" (no specific results provided, but compliance is stated).
6. Thermal, Electrical, and Mechanical Safety.	"evaluated for... thermal, electrical and mechanical safety" (no specific results provided, but compliance is stated).

In conclusion, the document explicitly states that no clinical studies were conducted for this 510(k) submission. The device's acceptance is based on demonstrating substantial equivalence to a predicate device through comprehensive non-clinical testing and adherence to recognized safety and performance standards.

Summary

{0}------------------------------------------------

January 2, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K172860

Trade/Device Name: Resona 6/Resona 6T/Resona 6Elite/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 1, 2017 Received: December 4, 2017

Dear Ma Chao:

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 of medical device-related adverse events) (21 CFR 803); good

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K172860

Device Name

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 57/Resona 5EXP/Resona 5Elite 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)

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 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 Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

N/A Transducer:

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	N	N	N	N	N	N	N	Note 1, 2, 3, 4, 5, 6, 7
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 3, 4, 5, 6, 7,10, 14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4, 7
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1, 2, 4, 7, 8, 12, 13
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4, 5, 6, 7, 10
	Trans-rectal	N	N	N	N	N	N	N	Note 1, 2, 3, 4, 6, 7
	Trans-vaginal	N	N	N	N	N	N	N	Note 1, 2, 3, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4, 6, 7, 8, 10,12, 13
	Musculo-skeletal(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4, 7, 8, 12, 13
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2, 4, 5, 6, 7,9,10
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4, 5, 6, 7,10
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4, 6, 7, 8, 10,11, 12, 13
	Other (Specify***)	N	N	N	N	N	N	N	Note 1, 2, 4, 6, 7

{4}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

C5-1U

Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,10
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,10,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,10
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,10
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	** Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4, 5, 6, 10
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4, 6, 10
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
	Prescription USE (Per 21 CFR 801.109)
Clinical Application	Mode of Operation
General	Specific	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
(Track 1 Only)	(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	N=new indication; P=previously cleared by FDA (K171233);			E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
(Track 1 Only)	(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1, 3, 4, 5, 6
& Other	Abdominal	P	P	P		P	P	P	Note 1, 3, 4, 6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233);				E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application					Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
(Track 1 Only)	(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233);					E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4, 7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4, 7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1, 2, 4, 7,8,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1, 2, 4, 7, 8,12,13
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1, 2, 4, 7, 8,12,13
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4, 7
	Other (Specify***)
N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power + B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
Note12: STE
Note13: STQ
Note14: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General	Specific	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
(Track 1 Only)	(Track 1 & 3)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4, 7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4, 7
	Small Organ (Specify**)	P	P	P	P	P	P	P	Note 1,2,4,7,8,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P	P	P	P	P	Note 1, 2, 4, 7, 8,12,13
	Musculo-skeletal(Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4, 7, 8,12,13
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4, 7, 11
	Other (Specify***)
Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4, 5, 6, 7,10
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P	Note 1, 2, 4, 5, 6, 7,10
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult	P	P	P	P	P	P	P	Note 1, 2, 4, 5, 6, 7,9,10
	Cardiac Pediatric	P	P	P	P	P	P	P	Note 1, 2, 4, 5, 6, 7,10
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
	Additional comments: Combined modes--B+M、PW+B、Color+B、Power+B、PW+Color+B、Power + PW +B.
	*Intraoperative includes abdominal, thoracic, and vascular.
	**Small organ-breast, thyroid, testes.
	***Other use includes Urology.
	Note 1: Tissue Harmonic Imaging.
	Note 2: Smart3D
	Note 3:4D(Real-time 3D)
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note8: Strain Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	Note12: STE
	Note13: STQ
	Note14: Contrast imaging (Contrast agent for Liver)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 3, 4, 6, 7
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
Additional comments: Combined modes--B+M\u3001PW+B\u3001Color + B\u3001Power + B\u3001PW+Color+B\u3001Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
Note12: STE
Note13: STQ
Note14: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4, 5, 6,7,10
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4,6,7,10,14
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1, 2, 4,6,7,10
	Musculo-skeletal(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4,6,7,10
	Other (Specify***)
	N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix EAdditional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B.Intraoperative includes abdominal, thoracic, and vascular.Small organ-breast, thyroid, testes.**Other use includes Urology.Note 1: Tissue Harmonic Imaging.Note 2: Smart3DNote 3:4D(Real-time 3D)Note 4: iScapeNote 5: TDINote 6: Color MNote 7: Biopsy GuidanceNote8: Strain ElastographyNote 9: Contrast imaging (Contrast agent for LVO)Note 10: Ultrasound Fusion ImagingNote 11: V FlowNote12: STENote13: STQNote14: Contrast imaging (Contrast agent for Liver)(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)Prescription USE (Per 21 CFR 801.109)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1, 2, 4
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1, 2, 4
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1, 2, 4
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4
	Other (Specify***)
N=new indication; P=previously cleared by FDA (K171233); E=added under Appendix E
Additional comments: Combined modes--B+M、PW+B、Color + B、Power+B、PW+Color+B、Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3:4D(Real-time 3D)
Note 4: iScape
Note 5: TDI
Note 6: Color M
Note 7: Biopsy Guidance
Note8: Strain Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
Note12: STE
Note13: STQ
Note14: Contrast imaging (Contrast agent for Liver)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1,2, 4,7,8,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1,2, 4,7,8,12,13
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1,2, 4,7,8,12,13
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1,2, 4,7,8,11,12,13
	Other (Specify***)
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Combined(specify)	Other(specify)
Ophthalmic	Ophthalmic
Fetal Imaging& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1, 2, 4, 8,12,13
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal(Conventional)	P	P	P		P	P	P	Note 1, 2, 4, 8,12,13
	Musculo-skeletal(Superficial)	P	P	P		P	P	P	Note 1, 2, 4, 8,12,13
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheralvessel	Peripheral vessel	P	P	P		P	P	P	Note 1, 2, 4
	Other (Specify***)

{5}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: SC8-2U

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

{6}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: V11-3HU

{7}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: D8-4U

{8}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

DE10-3U Transducer:

{9}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: L14-6WU

{10}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: L11-3U

{11}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: SP5-1U

{12}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: DE11-3U

{13}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: SC5-1U

{14}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: L20-5U

{15}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona
5EXP/Resona 5Elite Diagnostic Ultrasound System

L9-3U Transducer:

{16}------------------------------------------------

System:

Resona 6/Resona 6T/Resona 6Elite/Resona 6S/Resona 6S/Resona 6OB/Resona 5/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System

Transducer: L14-5WU

{17}------------------------------------------------

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).

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: September 15, 2017

2. Device Name:

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 60B/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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. Device Description:

Image /page/17/Picture/13 description: The image shows the number 007-1 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 1.

{18}------------------------------------------------

B-Mode, M-Mode, PW-Mode, CW-Mode, Color-Mode, Power/Dirpower Mode, THI, iScape mode, TDI mode, Color M, Strain Elastography, 3D/4D mode, Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for LVO), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode, B/PW-mode, B/PW/Color).

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

4. Intended Use:

The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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), adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), adult and pediatric cardiac, peripheral vessel, urology exam.

5. Comparison with Predicate Devices:

The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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	M9	K171034

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same intended uses as the predicated device Resona 7 (K171233).

{19}------------------------------------------------

Items	Subject DeviceResona 6/Resona 6T/Resona6EXP/Resona 6Elite/Resona6S/Resona 6PRO/Resona6OB/Resona 5/Resona5T/Resona 5EXP/Resona5Elite	Predicate deviceResona 7(K171233)
IntendedUse	The Resona 6/Resona 6T/Resona6EXP/Resona 6Elite/Resona6S/Resona 6PRO/Resona6OB/Resona 5/Resona 5T/Resona5EXP/Resona 5Elite DiagnosticUltrasound System is applicablefor adults, pregnant women,pediatric patients and neonates. Itis intended for use in fetal,abdominal, pediatric, small organ(breast, thyroid, testes), adultcephalic, trans-rectal,trans-vaginal, musculo-skeletal(conventional, superficial), adultand pediatric cardiac, peripheralvessel, urology exam.	Resona 7 Diagnostic UltrasoundSystem is applicable for adults,pregnant women, pediatricpatients and neonates. It isintended for use in fetal,abdominal, intra-operative(abdominal, thoracic, andvascular), pediatric, small organ(breast, thyroid, testes), neonatalcephalic, adultcephalic, trans-rectal,trans-vaginal, musculo-skeletal(conventional, superficial),cardiac adult,cardiac pediatric,trans-esoph. (cardiac) ,peripheralvessel, and urology exams.

● The patient contact materials of the transducers are tested under ISO 10993-1.

● The acoustic power levels of Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite are below the limits of FDA, which are the same as the predicated device Resona 7 (K171233).

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has the same imaging modes as the predicated devices.
All of the functions of Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite are the same as the predicated devices.
The Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite has similar tranducers with the predicated devices.

Image /page/19/Picture/7 description: The image shows the number 007-3 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 3.

{20}------------------------------------------------

6. Non-clinical Tests:

Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 60B/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite 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).
AAMI / ANSI / IEC 60601-1-2:2007/(R)2012, medical electrical equipment part 1-2: general requirements for basic safety and essential performance collateral standard: electromagnetic compatibility - requirements and tests (edition 3).
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 2.0 2007. 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 62304:2006, medical device software - software life cycle processes.
AAMI / ANSI / IEC 62366:2007/(R)2013, 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.

7. Clinical Studies

Not applicable. The subject of this submission, Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System, does not require

Image /page/20/Picture/14 description: The image shows the number 007-4 in a bold, sans-serif font. The numbers are black and the background is white. The numbers are evenly spaced and the hyphen is centered between the 7 and the 4.

{21}------------------------------------------------

clinical studies to support substantial equivalence.

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 6T/Resona 6EXP/Resona 6Elite/Resona 6S/Resona 6PRO/Resona 6OB/Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Regulation Number and Section

N/A