M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K103677
• Device Name: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2011-01-31 ( 46 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K100830 , K101041 , K060542 , K093563 , K050240 , K053069 , K072365 , K092271 , K061682 , K091374
• Predicate For: K111435 , K113153 , K113632 , K113647 , K120699 , K121010

Intended Use

The M7/M7T 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) exams.

Device Description

M7/M7T 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 with a frequency range of approximately 2.5 MHz to 10.0 MHz.

AI/ML Overview

The provided text [K103677](https://510k.innolitics.com/search/K103677) is a 510(k) Pre-Market Notification for the M7/M7T Diagnostic Ultrasound System. This document focuses on establishing substantial equivalence to existing predicate devices and ensuring the device meets various safety and electrical standards. It does not contain the specific types of performance studies or acceptance criteria that would typically be associated with AI/CADe devices.

In the context of the provided document, the "acceptance criteria" primarily refer to compliance with recognized medical device safety standards and demonstrating substantial equivalence to predicate devices, rather than performance metrics for an AI algorithm. Therefore, the information requested in the prompt, which is geared towards AI/CADe device evaluation, is largely absent from this 510(k) summary.

Here's a breakdown of why many sections of your request cannot be fulfilled based on the provided text:

• No AI/CADe Device: The M7/M7T Diagnostic Ultrasound System is described as a general-purpose diagnostic ultrasound system. There is no mention of any AI or CADe (Computer-Aided Detection/Diagnosis) functionality within the device. Thus, there is no AI algorithm to evaluate.

Given this, I cannot provide the requested information that pertains to AI/CADe device performance or clinical studies. The document only describes the device's technical characteristics, intended use, and conformance to general safety and electrical standards.

If you have a different document that describes an AI/CADe device, I would be happy to analyze it according to your criteria.

Summary

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

510(K) SUMMARY

JAN 3 1 201

x103677

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

The assigned 510(k) number is:

1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

Zhai Pei

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

October 18, 2010 Date Prepared:

2. Device Name: M7/M7T 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 (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

3. Device Description:

M7/M7T 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

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and phased array with a frequency range of approximately 2.5 MHz to 10.0 MHz.

12 / 11

4. Intended Use:

The M7/M7T 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) exams.

5. Comparison with Predicate Devices:

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

Predicate Device	Manufacturer	Model	510(k) Control Number
1	Mindray	M7/M7J	K100830
2	Mindray	DC-7	K101041
3	GE	VIVID 7	K060542
4	Philips	iU22	K093563
5	Siemens	Acuson CV70	K050240
6	SonoSite	SonoSite MicroMaxx	K053069
7	Siemens	SEQUOIA	K072365
8	GE	LOGIQ E9	K092271
9	GE	Voluson E8	K061682
10	GE	Logiq E	K091374

They have the same technological characteristics, are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes as the predicate devices.

6. Non-clinical Tests:

M7/M7T 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: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37,IEC 62304,UL 60601-1, ISO14971 and ISO 10993-1.

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

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 Diagnostic Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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

Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head and wing. The eagle's head is facing to the left, and its wing is curved upward.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Shenzhen Mindray Bio-Medical Electronics Co., Ltd. % Mr. Jeff D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709-3995

JAN 3 1 201

Re: K103677

Trade/Device Name: M7/M7T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: January 14, 2011 Received: January 19, 2011

Dear Mr. Rongero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the M7/M7T Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C5-2s	P4-2s	L7-3s
V10-4s	P7-3s	L12-4s
V10-4Bs	4CD4s	L14-6Ns
7L4s	6C2s	P12-4s
L14-6s	7L5s	CW2s

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls . Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at [phone].

Sincerely Yours,

hul Dóh

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Indications for Use

510(k) Number (if known):

Device Name: M7/M7T Diagnostic Ultrasound System

Indications For Use:

The M7/M7T 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) exams.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Amel Dóthm

(Division Sign-Off Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K

Page 1 of _1

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System;

Transducer:

M7/M7T Diagnostic Ultrasound System 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	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1,2,3,4,6,7,8
	Abdominal	P	P	P	P	P	P	Note 1,2,3,4,5,6,7,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1,2,3,4,5,6,7,8
	Small organ(specify)**	P	P	P		P	P	Note 1,2,4,6,7,8
	Neonatal Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
FetalImaging& Other	Adult Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Trans-rectal	P	P	P		P	P	Note 1,2,4,6,7,8
	Trans-vaginal	P	P	P		P	P	Note 1, 2,4,6,7,8,
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletalConventional	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Musculo-skeletalSuperficial	P	P	P		P	P	Note 1,2,4,6,7,8
	Intravascular
	Other (specify)***	P	P	P		P	P	Note 1, 2, 4,6,7,8
Cardiac	Cardiac Adult	P	P	P	P	P	P	Note 1,2,5,6,7,8
	Cardiac Pediatric	P	P	P	P	P	P	Note 1,2,5,6,7,8
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments: Combined modes; B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

• Note7: Biopsy Guidance
  Note8: Amplitude Doppler

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103677

Prescription USE (Per 21 CFR 801.109)

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

Item:	M7/M7T Diagnostic Ultrasound System
Transducer:	CS-2s

Intended Use:

Syste: Trans

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	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Abdominal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1, 2, 4,6,7,8
	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	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

.

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

• Note 4: iScape
  NoteS: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K103677

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

M7/M7T Diagnostic Ultrasound System
V10-4s
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follow

Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	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, 4,6,7,8
	Trans-vaginal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***	P	P	P		P	P	Note 1, 2, 4,6,7,8
	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; 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. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

• Note 4: iScape
  Noteš: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

Prescription USE (Per 21 CFR 801.109)

008-4

Diagnostic Ultrasound Indications for Use Form

. ඒ

Transducer; Intended Use:

System:

008-4

510K: K102627

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

V 10-4Bs

M7/M7T Diagnostic Ultrasound System

Transducer: Intended Use:

System:

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

	Clinical Application		Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	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, 4,6,7,8
	Trans-vaginal	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify) ***	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

• Note 4: iScape
• Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Dia

510K K103677

Prescription USE (Per 21 CFR 801,109)

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

7L4s

System:

M7/M7T Diagnostic Ultrasound System

Transducer:

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

Intended Use:

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

• Note 3:4D(Real-time 3D)
• Note 4: iScape

Note5: TDI

Note6: Color M

• Note7: Biopsy Guidance
  Note8: Amplitude Doppler

M.A. SD OK
(Division Sign-Off)

(Divisio Division of Radio Office of In

510K K103627

Prescription USE (Per 21 CFR 801.109)

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

System: Transducer; M7/M7T Diagnostic Ultrasound System L14-6s

Intended Use:

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

Clinical Application			Mode of Operation
General(Track IOnly)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 4,6,7,8
	Small organ(specify) **	P	P	P		P	P	Note 1,2, 4,6,7,8
FetalImaging& Other	Neonatal Cephalic	P	P	P		P	P	Note 1,2, 4,6,7,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P		P	P	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial	P	P	P		P	P	Note 1,2, 4,6,7,8
	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, 4,6,7,8
	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW+Color+ B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D - -

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Prescription USE (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K h103677

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

System:			M7/M7T Diagnostic Ultrasound System
Transducer:		P4-2s
Intended Use:			Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application	Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
	Ophthalmic Ophthalmic
	Fetal
	Abdominal	P	P	P	P	P	P	Note 1, 2,5,6,7,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,7,8
	Small organ(specify)**
Fetal	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7,8
Imaging	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7,8
& Other	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, 2,5,6,7,8
	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,7,8
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

• **Small organ-breast, thyroid, testes.
• ***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents

Note 2: Smart3D

Note 3: 4D(Real-time 3D)

Note 4: iScape

NoteS: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Prescription USE (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnosti

K103622
510K

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

System:			M7/M7T Diagnostic Ultrasound System
Transducer:		P7-3s
Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
General(Track 1Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	P.	P	P	P	P	P	Note 1, 2,5,6,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,8
	Small organ(specify)**
FetalImaging	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,8
& Other	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P	P	P	P	Note 1, 2,5,6,8
	Musculo-skeletal Superficial
	Intravascular
	Other (specify) ***
	Cardiac Adult	P	P	P	P	P	P	Note 1, 2,5,6,8
	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,8
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B,

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Mark D. Okker

(Division Sign-Off, Division of Radiological Device Office of In Vitro Diagnostic and Safety

510K K103627

Prescription USE (Per 21 CFR 801.109)

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

í

System:	M7/M7T Diagnostic Ultrasound System
Transducer:	4CD4s
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	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note 1,2, 3, 4,6,8
	Abdominal	P	P	P		P	P	Note 1,2, 3, 4,6,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P		P	P	Note 1,2, 3, 4,6,8
	Small organ(specify)**
FetalImaging& Other	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletalConventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

Diagnostic Ultrasound Indications for Use Form

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color +B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

• **Small organ-breast, thyroid, testes.

• ***Other use includes urology.

• ت

---

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

	(Division Sign-Off)
	Division of Radiological Devices
	Office of In Vitro Diagnostic Device Evaluation and Safety
510K.	K103677

Prescription USE (Per 21 CFR 801.109)

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

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

6C2s

M7/M7T Diagnostic Ultrasound System

System: Transducer: Intended Use:

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B,

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Arshod D. Kh.

Division Sign-O Division of Radiological Devi Office of In Vitro

510K K103627

Prescription USE (Per 21 CFR 801.109)

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

M7/M7T Diagnostic Ultrasound System

System: Transducer:

7L5s

Intended Use:

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

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

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

• **Small organ-breast, thyroid, testes.
• ***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

• Note 2: Smart3D
• Note 3:4D(Real-time 3D)
• Note 4: iScape
• Note5: TDI
• Note6: Color M
• Note7: Biopsy Guidance

Note8: Amplitude Doppler

Andrew D. Hinkle

Division of Radiological Devices Evaluation and Safety Office of In Vitro Diagnostic D

510K K103677

Prescription USE (Per 21 CFR 801.109)

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

Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	Note 1,2, 4,6,7,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1,2, 4,6,7,8
	Small organ(specify)**	N	N	N		N	N	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	N	N	N		N	N	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial	N	N	N		N	N	Note 1,2, 4,6,7,8
	Intravascular
	Other (specify) ***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	N	N	N		N	N	Note 1,2, 4,6,7,8
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Transducer:

L7-3s

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices

Division of Radiological D Davice Evaluation and Safety Office of In Vitro Diagnostic

Prescription USE (Per 21 CFR 801.109)

:

^

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

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	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal	N	N	N		N	N	Note 1,2, 4,6,7,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1,2, 4,6,7,8
	Small organ(specify)**	N	N	N		N	N	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	N	N	N		N	N	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial	N	N	N		N	N	Note 1,2, 4,6,7,8
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	N	N	N		N	N	Note 1,2, 4,6,7,8
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Transducer:

L12-4s

Diagnostic ultrasound imaging or fluid fle

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW +Color+B, PW +Color+B, Power + PW+B,

*Intraoperative includes abdominal, thoracic, and vascular.

Prescription USE (Per 21 CFR 801.109)

**Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

・

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)
Division of Radiological Devices

Office of In Vitro Diagnostic Device Eand Safet

510K K103622

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

System:

Transducer:

		Diagnostic ultrasound imaging or fluid flow analysis of the human body
Intended Use:	Clinical Application	as follows:
		B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
General(Track 1 Only)	Specific(Track 1 & 3)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N		N	N	Note 1,2, 4,6,7,8
	Small organ(specify)**	N	N	N		N	N	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	N	N	N		N	N	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial	N	N	N		N	N	Note 1,2, 4,6,7,8
	Intravascular
	Other (specify)***
	Cardiac Adult
	Cardiac Pediatric
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	N	N	N		N	N	Note 1,2, 4,6,7,8
	Other (specify)

Diagnostic Ultrasound Indications for Use Form

L 14-6Ns

M7/M7T Diagnostic Ultrasound System

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.

N=new indication; P=previously cleared by FDA; E=added under Appendix E

**Small organ-breast, thyroid, testes.

*** Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D Note 3:4D(Real-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

(Division Sign-Off)

Division of Radiological Devices Jffice of In Vitro Diagnostic De Evaluation and Safety

510K K103627

Prescription USE (Per 21 CFR 801.109)

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

Intended Use:			Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	Note 1, 2,5,6,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	Note 1, 2,5,6,8
	Small organ(specify)**
	Neonatal Cephalic	N	N	N	N	N	N	Note 1, 2,5,6,8
	Adult Cephalic	N	N	N	N	N	N	Note 1, 2,5,6,8
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify) ***
Cardiac	Cardiac Adult	N	N	N	N	N	N	Note 1, 2,5,6,8
	Cardiac Pediatric	N	N	N	N	N	N	Note 1, 2,5,6,8
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Transducer:

P12-4s

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. The feature does not use contrast agents.

Note 2: Smart3D

• Note 3:4D(Real-time 3D)
• Note 4: iScape

NoteS: TDI

Note6: Color M

• Note7: Biopsy Guidance
  Note8: Amplitude Doppler

Office of In tion and Safety

510K K103627

Prescription USE (Per 21 CFR 801.109)

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

Intended Use:		Diagnostic ultrasound imaging or fluid flow analysis of the human bodyas follows:
	Clinical Application	Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric				N
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic				N
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult				N
	Cardiac Pediatric				N
Cardiac	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Transducer:

CW2s

N=new indication; P=previously cleared by FDA; E=added under Appendix E

Additional comments:Combined modes: B+M, PW+B, Color + B, PW+Color+B, PW +Color+B, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vascular.

** Small organ-breast, thyroid, testes.

***Other use includes urology.

Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D

• Note 3:4D(Real-time 3D)
  Note 4: iScape

Note5: TDI

Note6: Color M

• Note7: Biopsy Guidance
  Note8: Amplitude Doppler

M.D. Dill
(Division Sign-Off)

Division of Radiological Dev Office of In Vitro Diagnostic Device

510K K103627

Prescription USE (Per 21 CFR 801.109)

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.