Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, deep learning, or any related terms, nor does it describe features typically associated with AI/ML in medical imaging (e.g., automated measurements, image segmentation, or diagnostic assistance powered by learning algorithms). The performance studies listed are standard electrical and safety compliance tests, not performance evaluations of AI/ML algorithms.

Therapeutic

No
The device is described as a "diagnostic ultrasound system" intended to "acquire and display ultrasound images," which indicates it is used for diagnosis, not treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is a "diagnostic ultrasound system," and the "Device Description" also refers to it as a "Diagnostic Ultrasound System."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Diagnostic Ultrasound System" and a "Track 3 device that employs an array of probes." This indicates the device includes hardware components (the ultrasound system and probes) in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is a "diagnostic ultrasound system" used for various imaging exams on patients. This involves using ultrasound waves to create images of internal structures, which is a form of in vivo (within a living organism) diagnostic imaging.
Device Description: The description details the system's function as acquiring and displaying ultrasound images using different modes. This aligns with in vivo imaging techniques.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) in vitro (outside the body). IVD devices are specifically designed for testing these types of samples to provide diagnostic information.

The device is a medical imaging device used for in vivo diagnosis, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 7OB 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), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

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

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound 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, TDI mode, 3D/4D mode, Color M-mode, iScape mode, Elastography, LVQ, Ultrasound Fusion Imaging, V Flow or the combined mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 13.5MHz.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid, testes), Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (conventional, superficial), Cardiac Adult, Cardiac Pediatric, Peripheral Vessel, Urology.

Indicated Patient Age Range

adults, pregnant women, pediatric patients and neonates.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

. AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. AAMI/ANSI/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304: Medical device software - Software life cycle processes
IEC:62366:Medical devices application of usability engineering to medical devices .
1 IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
ISO14971: Medical devices - Application of risk management to medical devices
. UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

These non-clinical tests relied on in this premarket notification submission can support the determination of substantial equivalence of the subject device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152763, K150080, K152567

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

September 6, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Zhai Pei Engineer of Technical Regulation Department Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen 518057 P.R. CHINA

Re: K162267

Trade/Device Name: Resona 7/ Resona 7CV/ Resona 7EXP/ Resona 7S/ Resona 70B 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: August 5, 2016 Received: August 11, 2016

Dear Mr. Pei:

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

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

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

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Ocls

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)

K162267

Device Name

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B

Indications for Use (Describe)

The Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 7OB 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), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

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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3

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System
Transducer:	N/A
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General	Specific (Track 1 & 3)					Color	Amplitude	Combined		Other
(Track 1		B	M	PWD	CWD	Doppler	Doppler	(specify)		(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P		P	P	P		Note 1,2,3,4,6,7,10
& Other	Abdominal	P	P	P	P	P	P	P		Note 1,2,3,4,5,6,7,10
	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
	Neonatal Cephalic
	Adult Cephalic	P	P	P	P	P	P	P		Note 1, 2, 4, 5, 6, 7,10
	Trans-rectal	P	P	P		P	P	P		Note 1, 2, 3, 4, 6, 7
	Trans-vaginal	P	P	P		P	P	P		Note 1, 2, 3, 4, 6, 7
	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)	P	P	P		P	P	P		Note 1, 2, 4, 7
	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
Peripheral	Peripheral vessel	P	P	P		P	P	P		Note 1, 2, 4, 6, 7,10,11
vessel	Other (Specify***)	P	P	P		P	P	P		Note 1, 2, 4, 6, 7
	N=new indication; P=previously cleared by FDA(K152763);						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:Static 3D/4D
	Note 4: iScape
	Note 5: TDI
	Note 6: Color M
	Note 7: Biopsy Guidance
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Transducer:		C5-1U
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
General
(Track 1	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
	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
Peripheral
vessel	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(K152763); 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
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Transducer:	SC8-2U
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P	Note 1, 2, 4, 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
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K152763); 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
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System
Transducer:	V11-3HU
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
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

Peripheral
vessel	Peripheral vessel
	Other (Specify***)	P	P	P		P	P	P	Note 1, 2, 4, 6, 7
	N=new indication; P=previously cleared by FDA(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Transducer:	D8-4U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application			Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P		P	P	P	Note 1, 3, 4, 6
	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
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	DE10-3U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
	General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler		Combined
(specify)	Other
(Specify)
	Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	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	Note 1, 3, 4, 6, 7
	Trans-vaginal	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
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
Mode of Operation
General	Specific (Track 1 & 3)					Color	Amplitude	Combined		Other
(Track 1		B	M	PWD	CWD	Doppler	Doppler	(specify)		(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	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
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
	Card.)
	Musculo-skeletal	P	P	P	P	P	P	P		Note 1, 2, 4, 7
	(Conventional)
	Musculo-skeletal	P	P	P	P	P	P	P		Note 1, 2, 4, 7
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	P	P	P	P	P	P	P		Note 1, 2, 4, 7
vessel	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763); 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

	Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

	Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L11-3U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application		Mode of Operation
	General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
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
	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
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4, 7
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4, 7, 11
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	Resona //Resona /CV/Resona /EXP/Resona /S/Resona /OB Diagnostic Ultrasound System
Transducer:	SP5-1U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Diagnostic Ultrasound Indications For Use Format

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5

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System System:

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7

8

9

10

11

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System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System
Transducer:	DE11-3U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application							Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other
(Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	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
Peripheral
vessel	Peripheral vessel
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K152763);						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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	Resona //Resona /CV/Resona /EXP/Resona /S/Resona /OB Diagnostic Ultrasound System			Transducer:	SC5-1U
		Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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
	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
Peripheral
vessel	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(K152763); 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
	Note 8: Elastography
	Note 9: Contrast imaging (Contrast agent for LVO)
	Note 10: Ultrasound Fusion Imaging
	Note 11: V Flow
	(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L20-5U
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	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	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	P	Note 1, 2, 4
	Musculo-skeletal
(Superficial)	P	P	P	P	P	P	P	Note 1, 2, 4
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	P	P	P	P	Note 1, 2, 4
	Other (Specify***)
N=new indication; P=previously cleared by FDA(K152763); 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
Note 8: Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic
Transducer:	L9-3U
	Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1,2, 4,7
	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
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1,2, 4,7
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1,2, 4,7
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1,2, 4,7,11
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; 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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9:Contrast imaging(contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L14-5WU
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
General
(Track 1	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4
	Intra-operative
(Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note 1, 2, 4,8
	Neonatal Cephalic
Fetal Imaging
& Other	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-
Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note 1, 2, 4
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note 1, 2, 4
	Intravascular
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note 1, 2, 4
	Other (Specify***)
	N=new indication; P=previously cleared by FDA; E=added under
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
Note5: TDI
Note6: Color M
Note7: Biopsy Guidance
Note8: Elastography
Note9:Contrast imaging(contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

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15

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7QB Diagnostic

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

16

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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).

The assigned 510(k) number is:

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 5604 Fax: +86 755 2658 2680

Contact Person:

Zhai Pei 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: August 5, 2016

Device Name: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B

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:

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound 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, TDI mode, 3D/4D mode, Color M-mode, iScape mode, Elastography, LVQ, Ultrasound Fusion Imaging, V Flow or the combined

18

mode (i.e. B/M-mode).This system is a Track 3 device that employs an array of probes that include linear array, convex array and phased array with a frequency range of approximately 3 MHz to 13.5MHz.

4. Intended Use:

The Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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), cardiac adult, cardiac pediatric, peripheral vessel and urology exams.

5. Summary of Modifications and New Added Features

This submission device is a modification to Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System previously cleared in K152763. The following is a brief overview of the modifications and new added features.

New added transducers 19-30 L14-5WU
. New added needle-guided bracket NGB-031
New added features ART Flow Velocity curve of V Flow MAPSE measurement and FAC calculation Schild and Persson fetal weight formulas GA formulas and FG formulas for fetal foot length

5. Comparison with Predicate Devices:

The modified Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 70B Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

| Predicate

Device	Manufacturer	Model	510(k) Number
1	Mindray	Resona 7	K152763
2	Mindray	DC-8	K150080
3	GE Healthcare	Voluson E8	K152567

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The modified Resona 7/Resona 7CV/Resona 7S/Resona 7S/Resona 70B Diagnostic Ultrasound System employs the same technology as the predicate devices. All systems transmit ultrasonic energy into patients, then 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 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B has the same intended uses as the predicated device Resona 7 (K152763).

| Items | Subject Device
Resona7/Resona7 OB/Resona7
CV/Resona7 EXP/Resona7S | Predicate device
Resona 7 (K152763) |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use | Resona 7/ Resona 7CV/ Resona
7EXP /Resona 7S/Resona 7OB
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),cardiac adult, cardiac
pediatric, peripheral vessel and
urology exams. | Resona 7 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),cardiac
adult, cardiac pediatric,
peripheral vessel and urology
exams. |

. The patient contact materials of the new added transducers and needle-guided bracket NGB-031are tested under ISO 10993-1.

. The acoustic power levels of the modified Resona 7/Resona 7CV/Resona 7EXP/ Resona 7S/Resona7OB are below the limits of FDA, which are the same as the predicated device Resona 7 (K152763).
. Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicated device Resona 7 (K152763).
1 The newly added features are identical as the predicated devices.

6. Non-clinical Tests:

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B 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.

20

Non-clinical tests relied on in this premarket notification submission for a determination of substantial equivalence include testing showing compliance with the following standards:

. AAMI/ANSI ES60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
. AAMI/ANSI/IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3)
. IEC 60601-2-37: Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
IEC 62304: Medical device software - Software life cycle processes
IEC:62366:Medical devices application of usability engineering to medical devices .
1 IEC 60601-1-6: medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
ISO14971: Medical devices - Application of risk management to medical devices
. UD 2: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
UD 3 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
. ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

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 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System, does not require 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 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.