M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound

• K Number: K172970
• Device Name: M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound
• Manufacturer: ShenZhen Mindray Bio-Medical Electronics Co., Ltd
• Date Cleared: 2017-10-25 ( 29 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) exams.

Device Description

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is a general purpose, portable/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, Color M-Mode, Power/Dirpower Mode, TDI mode 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.

Predicate Devices

K131690

Reference Devices

K171034

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard ultrasound system and does not mention any AI or ML capabilities in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as a "Diagnostic Ultrasound System" intended to "acquire and display ultrasound images," which falls under diagnostic rather than therapeutic uses.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System". The "Device Description" also mentions it is a "general purpose...ultrasound diagnostic system."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "software controlled, ultrasound diagnostic system" and mentions employing "an array of probes," which are hardware components essential for acquiring ultrasound images. The performance studies also include evaluations of hardware aspects like acoustic output, biocompatibility, and electrical/mechanical safety.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
• Device Description: The description clearly states that the M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is an ultrasound diagnostic system. Ultrasound works by sending sound waves into the body and interpreting the echoes to create images. This is an in vivo (within the living body) diagnostic method, not in vitro.
• Intended Use: The intended uses listed are all procedures performed directly on or within the patient's body (gynecology, obstetric, abdominal, etc.). There is no mention of analyzing samples taken from the body.

Therefore, this device falls under the category of medical imaging devices used for in vivo diagnosis, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) exams.

Product codes

IYN, IYO, ITX

Device Description

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is a general purpose, portable/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, Color M-Mode, Power/Dirpower Mode, TDI mode 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

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac)

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 were conducted for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, and mechanical safety. The device was found to conform with applicable medical safety standards, including AAMI / ANSI ES60601-1:2005/(R)2012, IEC 60601-1-2 Edition 3: 2007-03, IEC 60601-2-37 Edition 2.0 2007, AAMI / ANSI / IEC 62304:2006, ISO 14971 Second edition 2007-03-01, NEMA UD 2-2004 (R2009), and AAMI / ANSI / ISO 10993-1:2009/(R)2013.

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

Not Found

Predicate Device(s)

K131690

Reference Device(s)

K171034

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

October 25, 2017

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

Re: K172970

Trade/Device Name: M7/M7T/M7 Premium/M7 Expert/M7 Super 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: September 15, 2017 Received: September 26, 2017

Dear Yang Zhaohui:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.qov

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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'HaraFor

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)

K172970

Device Name

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System

Indications for Use (Describe)

The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transvaginal, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) 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

Diagnostic Ultrasound Indications for Use Form

System:	M7/M7T/M7 Premium/M7 Expert/M7 Super 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
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal	P	P	P	P	P	P	Note 1,2,3,4,6,7
	Abdominal	P	P	P	P	P	P	Note 1,2,3,4,5,6,7,9
	Intraoperative (specify)*	P	P	P	P	P	P	Note1,2,4,6,7
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1,2,3,4,5,6,7
	Small organ(specify)**	P	P	P	P	P	P	Note 1,2,4,6,7,8
	Neonatal Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7
	Adult Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7
	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	P	P	P	P	P	P	Note 1,2,4,5,6,7
	Musculo-skeletal Superficial	P	P	P	P	P	P	Note 1,2,4,6,7
	Intravascular
	Other (specify)***	P	P	P	P	P	P	Note 1, 2, 4,6,7
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1,2,5,6,7
	Cardiac Pediatric	P	P	P	P	P	P	Note 1,2,5,6,7
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note1,2,5,6
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P	P	P	P	Note 1, 2, 4,6,7
	Other (specify)

N=new indication; P=previously cleared by FDA(K131690, K171034); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

4

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:

C5-2s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7
	Abdominal	P	P	P		P	P	Note 1, 2, 4,6,7,9
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1, 2, 4,6,7
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1, 2, 4,6,7
Vascular	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

5

V10-4s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P		P	P	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	Note 1, 2, 4,6,7
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance; Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

6

V10-4Bs Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal	P	P	P		P	P	Note 1, 2, 4,6,7
	Trans-vaginal	P	P	P		P	P	Note 1, 2, 4,6,7
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	Note 1, 2, 4,6,7
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

7

7L4s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1,2, 4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	Note 1,2, 4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

8

L14-6s Transducer:

Clinical Application		Mode of Operation						Other (specify)
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	Note 1,2, 4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

9

P4-2s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	Note 1, 2,5,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,7
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7
	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P	P	P	P	Note 1, 2,5,6,7
	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

10

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:

P7-3s Transducer:

Clinical Application		Mode of Operation						Other (specify)
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	Note 1, 2,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1, 2,5,6
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6
	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P	P	P	P	Note 1, 2,5,6
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P	P	P	P	Note 1, 2,5,6
	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

11

Transducer: 4CD4s

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note1,2, 3, 4,6
	Abdominal	P	P	P		P	P	Note1,2, 3, 4,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note1,2, 3, 4,6
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

12

6C2s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1, 2, 4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1, 2, 4,6,7
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	Note 1, 2, 4,6,7
	Adult Cephalic	P	P	P		P	P	Note 1, 2, 4,6,7
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1, 2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1, 2, 4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1, 2, 4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

13

7L5s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
Vascular	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

14

L7-3s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1,2, 4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

15

L12-4s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1,2, 4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7,8
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

16

L14-6Ns Transducer:

	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/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7
	Small organ(specify)**	P	P	P		P	P	Note 1,2, 4,6,7,8
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7
	Other (specify)

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

17

P12-4s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	Note 1, 2,5,6
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1, 2,5,6
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6
	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P	P	P	P	Note 1, 2,5,6
	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

18

CW2s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric				P
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic				P
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult				P
	Cardiac Pediatric				P
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

19

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:

7LT4s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	Note1,2,4,6,7
	Intraoperative (specify)*	P	P	P	P	P	P	Note1,2,4,6,7
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note1,2,4,6,7
	Small organ(specify)**	P	P	P	P	P	P	Note1,2,4,6,7
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P	P	P	P	Note1,2,4,6,7
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P	P	P	P	Note1,2,4,6,7
	Musculo-skeletal Superficial	P	P	P	P	P	P	Note1,2,4,6,7
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P	P	P	P	Note1,2,4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

20

P7-3Ts Transducer:

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/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)	P	P	P	P	P	P	Note1,2,5,6
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

N=new indication; P=previously cleared by FDA(K131690); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

21

C11-3s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P	P	P		P	P	Note 1,2,4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2,4,6,7
	Small organ(specify)**
Fetal
Imaging
& Other	Neonatal Cephalic	P	P	P		P	P	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
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric	P	P	P		P	P	Note 1,2,4,6,7
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular	P	P	P		P	P	Note 1,2,4,6,7
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K171034); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

22

SP5-1s Transducer:

Clinical Application		Mode of Operation
General
(Track 1 Only)	Specific
(Track 1 & 3)	B	M	PWD	CWD	Color/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P	P	P	P	Note 1,2,4,6,7
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1,2,4,6,7
	Small organ(specify)**
	Neonatal Cephalic	P	P	P	P	P	P	Note 1,2,4,6,7
	Adult Cephalic	P	P	P	P	P	P	Note 1,2,4,6,7
& Other	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1,2,4,5,6,7
	Cardiac Pediatric	P	P	P	P	P	P	Note 1,2,4,5,6,7
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral
Vascular	Peripheral Vascular
	Other (specify)

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

N=new indication; P=previously cleared by FDA(K171034); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

Diagnostic Ultrasound Indications for Use Form

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M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System System:

Transducer: L16-4Hs

				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/
Amplitude
Doppler	Combined
(specify)	Other (specify)
Ophthalmic	Ophthalmic
Fetal
Imaging
& Other	Fetal
	Abdominal	P	P	P		P	P	Note1,2,4
	Intraoperative (specify)*	P	P	P		P	P	Note1,2,4
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note1,2,4
	Small organ(specify)**	P	P	P		P	P	Note1,2,4
	Neonatal Cephalic	P	P	P		P	P	Note1,2,4
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note1,2,4
	Musculo-skeletal Superficial	P	P	P		P	P	Note1,2,4
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular	P	P	P		P	P	Note1,2,4
Vascular	Other (specify)

N=new indication; P=previously cleared by FDA(K171034); 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;

Note5: TDI;

Note6: Color M;

Note7: Biopsy Guidance;

Note8: Strain Elastography;

Note9: Contrast imaging (Liver Only)

Concurrence of CDRH, Office of Device Evaluation(ODE)

24

510(K) SUMMARY

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

1. Submitter:

Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

Tel: [phone] Fax: [phone]

Contact Person:

Yang Zhaohui Shenzhen Mindray Bio-medical Electronics Co., LTD Mindray Building, Keji 12th Road South, Hi-tech Industrial Park, Nanshan, Shenzhen, 518057, P. R. China

September 15, 2017 Date Prepared:

2. Device Name: M7/M7T/M7 Premium/M7 Expert/M7 Super 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:

B-1

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M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is a general purpose, portable/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, Color M-Mode, Power/Dirpower Mode, TDI mode 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.

4. Intended Use:

The M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in gynecology, obstetric, abdominal, pediatric, small parts (breast, testes, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal(conventional and superficial), intraoperative and transesophageal(cardiac) exams.

5. Summary of Modifications

• I New Added Models: M7 Expert, M7 Super, M7 Premium
• l New Added Transducers: SP5-1s, L16-4Hs, C11-3s
• I New Added Needle-Guided Bracket: NGB-018
• Main Added Features: Contrast Imaging, Elastography

6. Comparison with Predicate Devices:

M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is comparable with and substantially equivalent to these predicate devices:

Predicate Device	Manufacturer	Model	510(k) Number
1.Primary predicate
device	Mindray	M7	K131690
5.Reference device	Mindray	M9	K171034

They have the same technological characteristics, are comparable in key safety and

26

effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

The materials of probes and Needle-guided brackets of M7/M7T/M7 Premium/M7 Expert/M7 Super are the same to the probe of predicate device.

The acoustic power levels of M7/M7T/M7 Premium/M7 Expert/M7 Super are below the limits of FDA, which are the same as the predicated device M7(K131690).

The M7/M7T/M7 Premium/M7 Expert/M7 Super has the same imaging modes as the predicated devices.

All of the functions of M7/M7T/M7 Premium/M7 Expert/M7 Super are the same as the predicated devices.

The M7/M7T/M7 Premium/M7 Expert/M7 Super have similar tranducers with the predicated devices.

7. Non-clinical Tests:

M7/M7T/M7 Premium/M7 Expert/M7 Super 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. This device has been designed to meet 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.
• AAMI / ANSI / IEC 62304:2006, medical device software software life cycle . processes.

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• 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. 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 M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.