Predicate Devices

Reference Devices

K170277, K151175, K163077, K162269, K153529, K081386, K153277

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with various imaging modes and features, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or algorithms that would typically indicate the presence of AI/ML technology. The performance studies focus on safety and standards compliance, not AI/ML performance metrics.

Therapeutic

No.
The device description and intended use clearly state that it is a "diagnostic ultrasound system" and its function is to "acquire and display ultrasound images," indicating it is for diagnosis, not therapy.

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 "general purpose, mobile, software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components.

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 describes the device as a diagnostic ultrasound system used for imaging various parts of the body in different patient populations. This is a typical description for an in-vivo imaging device, not a device that performs tests on samples taken from the body (in vitro).
Device Description: The description details the system's function in acquiring and displaying ultrasound images using various modes. This aligns with an imaging device, not an IVD.
Input Imaging Modality: The input is Ultrasound, which is an imaging modality used on the body, not a method for analyzing biological samples.
Anatomical Site: The listed anatomical sites are all locations within the human body where imaging is performed.
Performance Studies: The performance studies mentioned are non-clinical tests related to safety and acoustic output, which are relevant for imaging devices. There are no mentions of studies related to the accuracy of analyzing biological samples, which would be expected for an IVD.

IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates by sending and receiving ultrasound waves to create images of internal structures, which is a different principle of operation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Resona 7/Resona 7CV/Resona 7S/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, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal.musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.

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, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, trans-esoph. (cardiac) ,peripheral vessel, and urology exams.

Product codes

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, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, abdominal, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal, musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), peripheral vessel and urology exams.
Adult cephalic, musculo-skeletal (superficial).

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:
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 found to conform with applicable medical safety standards. 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 ES60601-1:2005/(R)2012 and A1:2012., c1:2009/(r)2012 and . a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
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.
I AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle processes.
ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices part 1: evaluation and testing within a risk management process.

Clinical Tests:
Not Applicable.

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

Not Found

Predicate Device(s)

K162267

Reference Device(s)

K170277, K151175, K163077, K162269, K153529, K081386, K153277

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 seal is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

September 12, 2017

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. % Zhai Pei Technical Manager of Technical Regulation Department Mindray Building Keji 12th Road South, Hi-tech Industrial Park Nanshan, Shenzhen 518057 P.R. CHINA

Re: K171233

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 2, 2017 Received: August 10, 2017

Dear Zhai 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

1

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.

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 Oolo

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171233

Device Name

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB diagnostic ultrasound system

Indications for Use (Describe)

The Resona 7/Resona 7CV/Resona 7S/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, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, trans-rectal, transvaginal.musculo-skeletal (conventional), cardiac adult, cardiac pediatric, trans-esoph. (cardiac), 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)

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."

3

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Transducer: N/A

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

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
Only)	General(Track 1 Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging &	Fetal	P	P	P	N	P	P	P	Note 1, 2,3, 4, 5, 6, 7,10,15
Other	Abdominal	P	P	P	N	P	P	P	Note 1, 2, 3,4, 5,6,
7,10,12,13,14,15,16
	Intra-operative (Specify*)	N	N	N	N	N	N	N	Note1,2,4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	N	P	P	P	Note 1, 2, 4, 6,7,10,15
	Small Organ (Specify**)	P	P	P	N	P	P	P	Note 1,2,4,7,8,10,12,13,15
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4,6,7
	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	P	Note 1, 2, 3,4, 6, 7,8
	Trans-vaginal	P	P	P	P	P	P	P	Note 1, 2, 3,4, 6, 7,8,16

	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	P	P	P	N	P	P	P	Note 1, 2, 4, 6, 7,8,10,12,13,15
	Musculo-skeletal
(Superficial)	P	P	P	N	P	P	P	Note 1, 2, 4, 7, 8,10,12,13,15
	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)	N	N	N	N	N	N	N	Note 1,5,6
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	N	P	P	P	Note 1, 2, 4, 6, 7,8,10,11,12,13,15
	Other (Specify***)	P	P	P	P	P	P	P	Note 1, 2, 4, 6, 7,8
	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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

4

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	C5-1U

Clinical Application							Mode of Operation
General (Track	Specific (Track 1 & 3)					Color	Amplitude	Combined
1 Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal	P	P	P	P	P	P	P	Note 1, 2, 4, 6, 7,10
& Other	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4, 6, 7,10,12,13,14,16
	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	P	P	P	P	P	P	P	Note 1, 2, 4, 6, 7,10
	(Conventional)
	Musculo-skeletal
	(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, 6, 7,10
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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

5

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 70B Diagnostic Ultrasound System
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 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
	Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	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, 10,16
		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
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)
Note15: Needle Navigation
Note16: GYN/Pelvic
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

6

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	V11-3HU

Clinical Application	Mode of Operation
General (Track 1 Only)	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, 7,8
	Trans-vaginal	P	P	P		P	P	P	Note 1, 2, 4, 6, 7,8,16
	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, 7,8
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: Strain Elastography
Note 9: Contrast imaging (Contrast agent for LVO)
Note 10: Ultrasound Fusion Imaging
Note 11: V Flow
Note 12: STE
Note 13: STQ
Note 14: Contrast imaging (Contrast agent for Liver)
Note 15: Needle Navigation
Note 16: GYN/Pelvic
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

7

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	D8-4U

Clinical Application		Mode of Operation
General (Track
1 Only)	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, 5, 6
	Abdominal	P	P	P		P	P	P	Note 1, 3, 4, 6,14,16
	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: 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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

8

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:
Mode of Operation
Clinical Application | | | | | | | | |
|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|-----------------------|-------------------------|
| General (Track
1 Only) | 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, 7,8 |
| | Trans-vaginal | P | P | P | | P | P | P | Note 1, 3, 4, 6, 7,8,16 |
| | 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 | | | | | | | | |
| | 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) | | | | | | | | | |
| Note15: Needle Navigation | | | | | | | | | |
| Note16: GYN/Pelvic | | | | | | | | | |
| (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) | | | | | | | | |

9

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L14-6WU

Clinical Application	Specific (Track 1 & 3)	B	M	PWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
General (Track 1 Only)
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
Peripheral vessel	Peripheral vessel	P	P	P	P	P	P	Note 1, 2, 4, 7
	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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

10

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						Other (Specify)
General (Track 1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler		Combined (specify)
Ophthalmic	Ophthalmic
Fetal Imaging & Other	Fetal	N	N	N	N	N	N	N	Note 1, 2, 4, 7,10,15
	Abdominal	P	P	P	N	P	P	P	Note 1, 2, 4, 7,10,15
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	N	P	P	P	Note 1, 2, 4, 7,10,15
	Small Organ (Specify**)	P	P	P	N	P	P	P	Note 1,2,4,7,8,10,12,13,15
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal (Conventional)	P	P	P	N	P	P	P	Note 1, 2, 4, 7, 8,10,12,13,15
	Musculo-skeletal (Superficial)	P	P	P	N	P	P	P	Note 1, 2, 4, 7, 8,10,12,13,15
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral vessel	Peripheral vessel	P	P	P	N	P	P	P	Note 1, 2, 4, 7,10, 11,15
	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
	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)
		Note15: Needle Navigation
		Note16: GYN/Pelvic
		(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)

11

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	SP5-1U

Clinical Application		Mode of Operation
General (Track
1 Only)	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
	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)
Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

12

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	DE11-3U

Clinical Application	Specific (Track 1 & 3)	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Combined (specify)	Other (Specify)
General (Track 1 Only)
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, 7,16
	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
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)
Note15: Needle Navigation
Note16: GYN/Pelvic
(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	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	P	P	P	P	P	P	P	Note 1, 2, 4, 5, 6,7,10,15
	Abdominal	P	P	P	P	P	P	P	Note 1, 2, 4,6,7,10,12,
13,14,15,16
	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	P	Note 1, 2, 4,6,7,10,15
	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	P	Note 1, 2, 4,6,7,10,15
	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
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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

13

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7OB Diagnostic Ultrasound System SC5-1U

Transducer:

14

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Transducer: L20-5U

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

Mode of Operation Clinical Application General (Track Specific (Track 1 & 3) Color Amplitude Combined PWD CWD B M Other (Specify) 1 Only) Doppler Doppler (specify) Ophthalmic Ophthalmic Fetal Imaging Fetal & Other 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 b P P P P P Note 1, 2, 4, 8 (Conventional) Musculo-skeletal P P P P P P Note 1, 2, 4, 8 (Superficial) Intravascular Cardiac Cardiac Adult Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Peripheral Peripheral vessel b b P P P P Note 1, 2, 4 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、PW +Color+B、PW +Color+B、Power + PW +B. *Intraoperative includes abdominal, thoracic, and vascular. **Small organ-breast, thyroid, testes. ***()ther 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) Note15: Needle Navigation Note16: GYN/Pelvic (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)

15

Svstem:	Resona 7/Resona 7CV/Resona 7EXP/Resona 70B Diagnostic Ultrasound System
100 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Transducer: L9-3U

Clinical Application		Mode of Operation
General(Track 1
Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1,2, 4,7
	Abdominal	P	P	P	N	P	P	P	Note 1,2, 4,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	N	P	P	P	Note 1,2, 4,7
	Small Organ (Specify**)	P	P	P	N	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	N	P	P	P	Note 1,2, 4,7,8,12,13
	Musculo-skeletal
(Superficial)	P	P	P	N	P	P	P	Note 1,2, 4,7,8,12,13
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	P	P	P	N	P	P	P	Note 1,2, 4,7,8,11,12,13
	Other (Specify***)

16

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L14-5WU

Clinical Application		Mode of Operation
General (Track	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (specify)
1 Only)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	P	Note 1, 2, 4,10,15
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	P	Note 1, 2, 4,10,15
	Small Organ (Specify**)	P	P	P		P	P	P	Note 1, 2, 4, 8,10,12,13,15
	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, 8,10,12,13,15
	Musculo-skeletal
(Superficial)	P	P	P		P	P	P	Note 1, 2, 4, 8,10,12,13,15
	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, 4,10,15
	Other (Specify***)
	N=new indication; P=previously cleared by FDA(K162267); 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: Strain Elastography
	Note9: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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)
Intended Use:
Clinical Application	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:						Mode of Operation
General (Track	Specific (Track 1 & 3)					Color	Amplitude	Combined
l Only)		B	M	PWD	CWD	Doppler	Doppler	(specify)	Other (Specify)
Ophthalmic	Ophthalmic
								N
Fetal Imaging	Fetal	N	N	N		N	N		Note 1, 2, 4, 5, 6,7,10,15
& Other	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7,10,12,13,14,15,16
	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	N	N	N		N	N	N	Note 1, 2, 4,6,7,10,15
	(Conventional)
	Musculo-skeletal
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7,10,15
vessel	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、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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note 1, 2, 4, 6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2, 4, 6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2, 4, 5, 6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2, 4, 5, 6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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
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)
Note15: Needle Navigation
Note16: GYN/Pelvic
(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)

17

Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System System: Transducer:
Intended Use SC6-1U

n It d imagin fluid flo alvsis of the hi i bodr foll Dia . •

18

Resona 7/Resona 7CV/Resona 7EXP/Resona 7OB Diagnostic Ultrasound System System: Transducer: P10-4U

Clinical Application

19

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	C6-2GU

Clinical Application

Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1,2,4,6,7
	Abdominal	N	N	N	N	N	N	N	Note 1,2,4,6,7,14,16
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1,2,4,6,7
	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; 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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Cardiac Pediatric	N	N	N		N	N	N	Note 1, 2, 4,6,7
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel	N	N	N		N	N	N	Note 1, 2, 4,6,7
	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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

20

Resona 7/Resona 7CV/Resona 7EXP/Resona 7OB Diagnostic Ultrasound System System: Transducer: C11-3U

Intended Use:
Clinical Application:

21

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	P7-3U

Transad Use:
Intended Use:
Clinical Applic

Clinical Application							Mode of Operation
General (Track	Specific (Track 1 & 3)	B	M	PWD	CWD	Color	Amplitude	Combined	Other (Specify)
1 Only)						Doppler	Doppler	(specify)
Ophthalmic	Ophthalmic
Fetal Imaging	Fetal
& Other	Abdominal	N	N	N	N	N	N	N	Note 1, 2,4,6
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,6
	Small Organ (Specify**)
	Neonatal Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6
	Adult Cephalic	N	N	N	N	N	N	N	Note 1, 2,4,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
	(Conventional)	N	N	N	N	N	N	N	Note 1, 2,4,6
	Musculo-skeletal
	(Superficial)
	Intravascular
Cardiac	Cardiac Adult	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Cardiac Pediatric	N	N	N	N	N	N	N	Note 1, 2,4,5,6
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral	Peripheral vessel
vessel	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、PW +Color+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)
	Note15: Needle Navigation
Note16: GYN/Pelvic

	(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)

22

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	P7-3TU

Intended Use.

Clinical Application:

Clinical Application		Mode of Operation
General (Track
1 Only)	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**)
	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)	N	N	N	N	N	N	N	Note 1,5,6
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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
	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)
Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

23

Resona 7/Resona 7CV/Resona 7EXP/Resona 7OB Diagnostic Ultrasound System System: Transducer: P7-3Ts

Clinical Application

Clinical Application		Mode of Operation							Other (Specify)
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	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)	N	N	N	N	N	N	N	Note 1,5,6
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

24

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L16-4HU

Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal	N	N	N	N	N	N	N	Note1,2,4
	Intra-operative (Specify*)	N	N	N	N	N	N	N	Note1,2,4
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	N	Note1,2,4
	Small Organ (Specify**)	N	N	N	N	N	N	N	Note1,2,4
	Neonatal Cephalic	N	N	N	N	N	N	N	Note1,2,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)	N	N	N	N	N	N	N	Note1,2,4
	Musculo-skeletal
(Superficial)	N	N	N	N	N	N	N	Note1,2,4
Cardiac	Intravascular
	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac

Peripheral
vessel	Peripheral vessel	N	N	N	N	N	N	N	Note1,2,4
	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
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)
Note15: Needle Navigation
Note16: GYN/Pelvic
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

25

System:	Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System
Transducer:	L16-4Hs

Intended Use.
Clinical Application:

| | Clinical Application
Mode of Operation | | | | | | | | |
|--------------------------|---------------------------------------------------------------------------------------------|---|---|-----|-----|--------------------------|----------------------|-----------------------|-----------------|
| General (Track | Specific (Track 1 & 3) | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Combined
(specify) | Other (Specify) |
| 1 Only) | | | | | | | | | |
| Ophthalmic | Ophthalmic | | | | | | | | |
| Fetal Imaging
& Other | Fetal | | | | | | | | |
| | Abdominal | N | N | N | N | N | N | N | Note1,2,4 |
| | Intra-operative (Specify*) | N | N | N | N | N | N | N | Note1,2,4 |
| | Intra-operative (Neuro) | | | | | | | | |
| | Laparoscopic | | | | | | | | |
| | Pediatric | N | N | N | N | N | N | N | Note1,2,4 |
| | Small Organ (Specify**) | N | N | N | N | N | N | N | Note1,2,4 |
| | Neonatal Cephalic | N | N | N | N | N | N | N | Note1,2,4 |
| | Adult Cephalic | | | | | | | | |
| | Trans-rectal | | | | | | | | |
| | Trans-vaginal | | | | | | | | |
| | Trans-urethral | | | | | | | | |
| | Trans-esoph. (non-Card.) | | | | | | | | |
| | Musculo-skeletal
(Conventional) | N | N | N | N | N | N | N | Note1,2,4 |
| | Musculo-skeletal
(Superficial) | N | N | N | N | N | N | N | Note1,2,4 |
| | Intravascular | | | | | | | | |
| Cardiac | Cardiac Adult | | | | | | | | |
| | Cardiac Pediatric | | | | | | | | |
| | Intravascular (Cardiac) | | | | | | | | |
| | Trans-esoph. (Cardiac) | | | | | | | | |
| | Intra-cardiac | | | | | | | | |
| Peripheral
vessel | Peripheral vessel | N | N | N | N | N | N | N | Note1,2,4 |
| | 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 | | | | | | | | |
| | 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) | | | | | | | | |
| | Note15: Needle Navigation
Note16: GYN/Pelvic | | | | | | | | |
| | | | | | | | | | |
| | (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) | | | | | | | | |

26

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Transducer: C4-1U

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

Mode of Operation Clinical Application General (Track Specific (Track 1 & 3) Color Amplitude Combined PWD CWD B M Other (Specify) 1 Only) Doppler Doppler (specify) Ophthalmic Ophthalmic Fetal Imaging Fetal E E E E E E Note 1, 2, 4,6,7,10 & Other E Note 1, 2, 4,6,7,10,14,16 Abdominal E E E E E Intra-operative (Specify*) Intra-operative (Neuro) Laparoscopic Pediatric N N N N N N Note 1, 2, 4,6,7,10 Small Organ (Specify**) Neonatal Cephalic Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal E E E E E E Note 1, 2, 4,6,7,10 (Conventional) Musculo-skeletal (Superficial) Intravascular Cardiac Cardiac Adult N N N N N N Note 1, 2, 4,6,7,10 Cardiac Pediatric Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Peripheral Peripheral vessel vessel 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、PW +Color+B、PW +Color+B、Power + PW +B. *Intraoperative includes abdominal, thoracic, and vascular. **Small organ-breast, thyroid, testes. ***()ther 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) Note15: Needle Navigation Note16: GYN/Pelvic (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)

27

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7OB Diagnostic Ultrasound System DE10-3WU

Transducer:

Clinical Application	Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1, 3,4,6,7
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	N	N	N	N	N	N	N	Note 1, 3,4,6,7
	Trans-vaginal	N	N	N	N	N	N	N	Note 1, 3,4,6,7,16
	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; 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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal
	Abdominal
	Intra-operative (Specify*)
	Intra-operative (Neuro)
	Laparoscopic
	Pediatric				N
	Small Organ (Specify**)
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal
(Conventional)
	Musculo-skeletal
(Superficial)
	Intravascular
Cardiac	Cardiac Adult				N
	Cardiac Pediatric				N
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-cardiac
Peripheral
vessel	Peripheral vessel
	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
	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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

28

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

CW5s Transducer:

29

System: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System Transducer: CW2s

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

Mode of Operation Clinical Application General (Track Specific (Track 1 & 3) Color Amplitude Combined PWD CWD B M Other (Specify) 1 Only) Doppler Doppler (specify) Ophthalmic Ophthalmic Fetal Imaging Fetal & Other Abdominal Intra-operative (Specify*) Intra-operative (Neuro) Laparoscopic Pediatric N Small Organ (Specify**) Neonatal Cephalic N Adult Cephalic Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Intravascular Cardiac Cardiac Adult N Cardiac Pediatric N Intravascular (Cardiac) Trans-esoph. (Cardiac) Intra-cardiac Peripheral Peripheral vessel vessel 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、PW +Color+B、PW +Color+B、Power + PW +B. *Intraoperative includes abdominal, thoracic, and vascular. **Small organ-breast, thyroid, testes. ***()ther 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) Note15: Needle Navigation Note16: GYN/Pelvic (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)

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Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System System: Transducer: D8-2U

Clinical Application		Mode of Operation
General (Track
1 Only)	Specific (Track 1 & 3)	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Combined
(specify)	Other (Specify)
Ophthalmic	Ophthalmic
Fetal Imaging
& Other	Fetal	N	N	N	N	N	N	N	Note 1, 3, 4, 5, 6, 7
	Abdominal	N	N	N	N	N	N	N	Note 1, 3, 4, 6, 7, 14,16
	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; 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)
	Note15: Needle Navigation
	Note16: GYN/Pelvic
	(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)

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

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: April 20, 2017

Device Name: Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB

Diagnostic Ultrasound System

Classification

Regulatory Class: II Review Category: Tier II 21 CFR 892.1550 Ultrasonic Pulsed Doppler Imaging System (90-IYN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-IYO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-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, THI, TDI mode, 3D/4D mode, Color M mode, iScape mode, Strain Elastography, Contrast imaging(LVO and Liver), Ultrasound Fusion Imaging, V Flow, STE, STQ or the combined mode (i.e. B/M-Mode).This system Page 1 of 5

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

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, intra-operative (abdominal, thoracic, and vascular), pediatric, small organ (breast, thyroid, testes), neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal (conventional, superficial), cardiac adult, cardiac pediatric, trans-esoph. (cardiac) ,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 K162267. The following is a brief overview of the modifications and new added features.

New added transducers
SC6-1U, P10-4U, C6-2GU, C11-3U, P7-3U, P7-3TU, P7-3Ts, L16-4HU, L16-4Hs, C4-1U, DE10-3WU, CW5s, CW2s, D8-2U
New added needle-guided brackets NGB-018, NGB-024, NGB-034, NGB-036, NGB-037, NGB-040

■ New added features

Contrast imaging (contrast agent for Liver) Add the ultrasound fusion imaging function to transducers L14-5WU, SC6-1U and L11-3U Needle Navigation Smart Face Smart Planes CNS Smart Planes FH Pelvic STE and STO Add strain elastography function to transducers V11-3HU, DE10-3U, L14-6WU, L11-3U, L20-5U, L9-3U and L14-5WU Add CW imaging mode to transducers L11-3U and L9-3U Add TDI mode under Fetal heart Add Smart Track function to transducers L9-3U, L14-5WU and L20-5U R-VQS Add exam mode of OB for linear transducers L9-3U and L11-3U

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6. Comparison to 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:

Device	Manufacturer	Model	510(k) Number
1.Primary predicate
device	Mindray	Resona 7	K162267
2.Reference device	Mindray	DC-8	K170277
3.Reference device	Zonare	ZS3	K151175
4.Reference device	GE
Medical Systems	LOGIQ E9	K163077
5.Reference device	GE Healthcare	Voluson E10	K162269
6.Reference device	Samsung
Medison	WS80A	K153529
7.Reference device	ESAOTE S.P.A.	Mylab70
6200	K081386
K153277

The modified Resona 7/Resona 7CV/Resona 7EXP/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 7S/Resona 7S/Resona 70B has the same intended use as the device DC-8(K170277)

Items	Subject Device	Predicate device
	Resona 7/Resona 7CV/
Resona 7EXP/
Resona 7S/Resona 7OB	DC-8 (K170277)
Intended
use	The Resona 7/Resona 7CV/
Resona 7EXP/Resona
7S/Resona 7OB diagnostic
ultrasound system is
applicable for adults,
pregnant women, pediatric
patients and neonates.	The DC-8/DC-8 PRO/DC-8
CV/DC-8 EXP diagnostic
ultrasound system is
applicable for adults,
pregnant women, pediatric
patients and neonates.
It is intended for use in fetal,

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| It is intended for use in fetal,

abdominal,	abdominal,
intra-operative(abdominal,
thoracic, and vascular),	intra-operative(abdominal,
thoracic, and vascular),
pediatric,	pediatric,
small organ (breast, thyroid,
testes), neonatal cephalic,	small organ (breast, thyroid,
testes), neonatal cephalic,
adult cephalic,	adult cephalic,
trans-rectal,	trans-rectal,
trans-vaginal,	trans-vaginal,
musculo-skeletal
(conventional, superficial),	musculo-skeletal
(conventional, superficial),
cardiac adult,	cardiac adult,
cardiac pediatric,	cardiac pediatric,
trans-esoph. (cardiac)	trans-esoph. (cardiac)
peripheral vessel,	peripheral vessel,
and urology exams.	and urology exams.

The patient contact materials of the new added transducers and needle-guided brackets are tested under ISO 10993-1.
1 The acoustic power levels of modified Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B are below the limits of FDA, which are the same as the predicate device Resona 7 (K162267).
The modified Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB is designed in compliance with the FDA recognized electrical and physical safety standards, which are the same as the predicate device Resona 7 (K162267).
The modified Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B has the same imaging modes as the predicate devices.
. The new added features of modified Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B are the same as the predicate devices.
. The modified Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 70B has similar transducers with the predicate devices.

7. 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 found to conform with applicable medical safety standards.

Non-clinical tests relied on in this premarket notification submission for a determination of Page 4 of 5

35

substantial equivalence include testing showing compliance with the following standards:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012., c1:2009/(r)2012 and . a2:2010/(r)2012 (consolidated text) medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
IEC 60601-1-2 Edition 3: 2007-03, medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic compatibility - requirements and tests.
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.
I AAMI / ANSI / IEC 62304:2006, medical device software - software life cycle processes.
ISO 14971 Second edition 2007-03-01, medical devices - application of risk management to medical devices.
NEMA UD 2-2004 (R2009), acoustic output measurement standard for diagnostic ultrasound equipment revision 3.
. AAMI / ANSI / ISO 10993-1:2009/(R)2013, biological evaluation of medical devices part 1: evaluation and testing within a risk management process.

8. Clinical Tests:

Not Applicable.

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 7EV/Resona 7EXP/Resona 7S/Resona 70B Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

Intended Use / Indications for Use

Product codes

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

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

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

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

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

Predicate Device(s)

Reference Device(s)

Predetermined Change Control Plan (PCCP) - All Relevant Information

§ 892.1550 Ultrasonic pulsed doppler imaging system.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K171233

Device Name

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

1. Submitter:

Contact Person:

Classification

3. Device Description:

4. Intended Use:

5. Summary of Modifications and New Added Features

■ New added features

6. Comparison to Predicate Devices:

7. Non-clinical Tests:

8. Clinical Tests:

Conclusion:

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!