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.

AI/ML Overview

This is a 510(k) premarket notification for an ultrasound system, not an AI/ML device. Therefore, the typical acceptance criteria and study designs applicable to AI/ML devices, such as sample sizes for test and training sets, expert qualifications, and comparative effectiveness studies, are not discussed in this document.

The provided document describes the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System (K172970). The acceptance criteria and the study proving the device meets these criteria are related to the safety and performance of a conventional diagnostic ultrasound system, not an AI/ML-driven device.

Here's the information extracted and contextualized for a non-AI medical device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this diagnostic ultrasound system are based on established medical safety standards and compliance with existing device functionalities. The device primarily aims for "substantial equivalence" to previously cleared predicate devices (Mindray M7, K131690, and Mindray M9, K171034).

Acceptance Criteria Category	Details/Standard	Reported Device Performance
Acoustic Output	Below the limits set by FDA, as per NEMA UD 2-2004 (R2009)	"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)."
Biocompatibility	Conforms to AAMI / ANSI / ISO 10993-1:2009/(R)2013	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... biocompatibility..." (Found to conform)
Cleaning & Disinfection	Conforms to applicable standards	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... cleaning and disinfection effectiveness..." (Found to conform)
Electrical Safety	Conforms to AAMI / ANSI ES60601-1:2005/(R)2012 (consolidated text)	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... electrical safety..." (Found to conform)
Thermal Safety	Conforms to AAMI / ANSI ES60601-1:2005/(R)2012 (consolidated text)	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... thermal... safety..." (Found to conform)
Mechanical Safety	Conforms to AAMI / ANSI ES60601-1:2005/(R)2012 (consolidated text)	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... mechanical safety..." (Found to conform)
Electromagnetic Compatibility (EMC)	Conforms to IEC 60601-1-2 Edition 3: 2007-03	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... electromagnetic compatibility..." (Found to conform)
Diagnostic Ultrasound Equipment	Conforms to IEC 60601-2-37 Edition 2.0 2007	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been evaluated for... diagnostic ultrasound equipment standards..." (Found to conform)
Medical Device Software Life Cycle	Conforms to AAMI / ANSI / IEC 62304:2006	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been designed to meet... AAMI / ANSI / IEC 62304:2006..."
Risk Management	Conforms to ISO 14971 Second edition 2007-03-01	"M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound System has been designed to meet... ISO 14971..."
Imaging Modes & Features	Same as predicate devices (Mindray M7 K131690, Mindray M9 K171034)	The device "has the same imaging modes as the predicated devices" and "All of the functions... are the same as the predicated devices."
Transducers & Materials	Similar to predicate devices; materials of probes and needle-guided brackets are the same.	The device has "similar transducers with the predicated devices" and "The materials of probes and Needle-guided brackets... are the same to the probe of predicate device."
Quality Systems	Conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality systems	"The design, development and quality process of the manufacturer confirms with 21 CFR 820, ISO 9001 and ISO 13485 quality systems."

Regarding the specific questions tailored for AI/ML devices, based on the provided general ultrasound device 510(k) summary, the following applies:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This document describes a traditional medical device (ultrasound system), not an AI/ML device. Therefore, there is no mention of a "test set" in the context of an algorithm's performance on a dataset of cases. The "testing" involves verification and validation against technical specifications and safety standards (e.g., electrical, acoustic output measurements) rather than evaluation on clinical image datasets.
- No information on data provenance (country of origin, retrospective/prospective) is applicable or provided for this type of submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. As this is not an AI/ML device, there is no "ground truth" established by experts on a test set of clinical images for algorithm validation. The "ground truth" for compliance testing would be the physical properties measured against established engineering and safety standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no concept of adjudication by human readers for a test set in the context of this traditional ultrasound device submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted device, so no MRMC study or AI-related comparative effectiveness analysis was conducted or reported.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a diagnostic ultrasound system operated by a human, not an algorithm that performs standalone diagnoses.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For a conventional ultrasound system, the "ground truth" for its performance evaluation would be defined by the accuracy and precision of its physical measurements (e.g., acoustic output, image quality metrics) against engineering specifications and regulatory limits, rather than clinical diagnoses or pathology reports.
The sample size for the training set:
- Not applicable. This document does not describe an AI/ML device, so there is no concept of a "training set" for an algorithm.
How the ground truth for the training set was established:
- Not applicable, for the same reason as above.

Summary

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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

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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

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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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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
FetalImaging& 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/AmplitudeDoppler	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
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric				P
	Small organ(specify)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	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)**
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& 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
PeripheralVascular	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/AmplitudeDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& 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)

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510(K) SUMMARY

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

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 5640 Fax: +86 755 2658 2680

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:

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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4. Intended Use:

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 predicatedevice	Mindray	M7	K131690
5.Reference device	Mindray	M9	K171034

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

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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.

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.