M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM

• K Number: K121010
• Device Name: M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD
• Date Cleared: 2012-04-19 ( 16 days)
• Product Code: IYN , ITX , IYO
• Regulation Number: 892.1550
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K103677 , K103583 , K113647 , K093563
• Predicate For: K130833 , K131690 , K132341

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, 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 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

Here's an analysis of the provided text regarding acceptance criteria and study information for the M7/M7T Diagnostic Ultrasound System:

Summary of Device Performance Study Information

The provided 510(k) summary for the M7/M7T Diagnostic Ultrasound System is for a general-purpose ultrasound device. As such, it primarily focuses on establishing substantial equivalence to predicate devices and adherence to safety and performance standards rather than presenting a clinical study with specific acceptance criteria related to diagnostic accuracy.

The document indicates that the device has been evaluated for:

• Acoustic output
• Biocompatibility
• Cleaning and disinfection effectiveness
• Thermal, electrical, and mechanical safety

It states that the device conforms to applicable medical safety standards, including UD 2, UD 3, IEC 60601-1 series, UL 60601-1, ISO14971, ISO 10993-1, IEC62304, and IEC60601-2-18.

Acceptance Criteria and Reported Device Performance

Since this is a filing for a general-purpose ultrasound system based on substantial equivalence, there are no specific diagnostic accuracy acceptance criteria or performance metrics (like sensitivity, specificity, AUC) reported in this summary. The "performance" being demonstrated here is primarily the device's adherence to relevant safety and performance standards, and its technological characteristics being comparable to predicate devices.

Acceptance Criteria Category	Reported Device Performance (Summary)
Safety Standards	Conforms to: UD 2, UD 3, IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-37, UL 60601-1, ISO14971, ISO 10993-1, IEC62304, IEC60601-2-18.
Functionality	Acquires and displays ultrasound images in B-Mode, M-Mode, PW-Mode, CW mode, Color-Mode, Color M-Mode, Power/Dirpower Mode, TDI mode or combined modes.
Technological Equivalence	Same technological characteristics and comparable key safety/effectiveness features as predicate devices.
Intended Use Equivalence	Same intended uses and basic operating modes as predicate devices.
Quality Systems	Conformance with 21 CFR 820, ISO 9001, and ISO 13485 quality systems.
Acoustic Output	Evaluated and found to conform to limits (implied by conformance to standards).
Biocompatibility	Evaluated and found to conform (implied by conformance to standards).
Cleaning/Disinfection	Evaluated for effectiveness (implied by conformance to standards).
Thermal/Electrical/Mechanical Safety	Evaluated and found to conform (implied by conformance to standards).

Specific Study Information Not Provided in this Document:

Based on the provided text, the following information is not available:

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No clinical test set or data from a diagnostic performance study is mentioned. The evaluation is focused on engineering and safety standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth study is described.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no clinical test set is described.
4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This document describes a general diagnostic ultrasound system, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical ground truth study is described.
7. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable as this is not an AI/machine learning device.

Conclusion from the Document:

The conclusion states that the "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."

This heavily implies that due to the nature of the device (a general-purpose ultrasound system) and the regulatory pathway chosen (510(k) substantial equivalence), the "study" demonstrating its meeting of acceptance criteria consists of:

• Verification and validation against engineering and safety standards (as listed above).
• Bench testing and performance verification to ensure the device functions as intended (e.g., imaging modes, frequency ranges).
• Comparison of its intended uses and technological characteristics to already cleared predicate devices.

There is no mention of a clinical trial or a study assessing the diagnostic accuracy or efficacy of the M7/M7T Diagnostic Ultrasound System in this summary. Such studies are typically not required for general-purpose ultrasound systems cleared via the 510(k) pathway when substantial equivalence to existing devices is established based on technical and functional similarities and adherence to recognized standards.

Summary

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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).

The assigned 510(k) number is: KIQIOIQ

1. Submitter:

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

Tel: [phone] Fax: [phone]

Contact Person:

Yang Zhaohui

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

Date Prepared: January 15, 2012

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-IYO)

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.

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, thyroid), neonatal cephalic, transcranial, cardiac, transvaginal, transrectal, peripheral vascular, urology, orthopedic, and musculoskeletal (conventional and superficial), intraoperative and transesophageal(cardiac) exams.

5. Comparison with Predicate Devices:

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

PredicateDevice	Manufacturer	Model	510(k) ControlNumber
1	Mindray	M7/M7T	K103677
2	Mindray	DC-7	K103583
3	Mindray	DC-8	K113647
4	GE	Logiq 7	K03218
5	Philips	iU22	K093563

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,UL 60601-1, ISO14971, ISO 10993-1, IEC62304 and IEC60601-2-18.

Conclusion:

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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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

Public Health Service

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

Re: K121010

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: March 30, 2012 Received: April 3, 2012

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	P7-3s	L14-6Ns
V10-4s	4CD4s	P12-4s
V10-4Bs	6C2s	CW2s
7L4s	7L5s	7LT4s
L14-6s	L7-3s	P7-3Ts
P4-2s	L12-4s

APR 1 9 2012

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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 Lauren Hefner at [phone].

Sincerely Yours,

Damme M. Morris

anine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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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); intraoperative and transesophagel (cardiac) 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)

Ranny Shouss
(Division Sign-
Division of Radiologica
Office of In Vitro Diagnostic Device Evalu
510K K121010

Page 1 of

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Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System

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	ColorDoppler	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	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)*	N	N	N	N	N	N	Note1,2,4,6,7,8
	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	P	Note 1,2,4,6,7,8
FetalImaging& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Adult Cephalic	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Trans-rectal	P	P	P	P	P	P	Note 1,2,4,6,7,8
	Trans-vaginal	P	P	P	P	P	P	Note 1,2,4,6,7,8
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Musculo-skeletal Superficial	P	P	P	P	P	P	Note 1,2,4,6,7,8
	Intravascular
	Other (specify)***	P	P	P	P	P	P	Note 1, 2, 4,6,7,8
	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)	N	N	N	N	N	N	Note 1,2,5,6,8
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	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 K121010

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System:	M7/M7T Diagnostic Ultrasound System
Transducer:	C5-2s
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 (specify)	CombinedDoppler (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
FetalImaging& Other	Small organ(specify)**
	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, 4,6,7,8
	Other (specify)

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

1+1cw multed.com, 1 - provents: 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 I: 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

Show

Olyision of Sacrologic Evaluation and Safety Office of 10

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Transducer:

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound System System:

V 10-4s

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

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	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
	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	Cardiac Adult
	Cardiac Pediatric
	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, PW +Color+B, PW +Color+B, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

• **Small organ-breast, thyroid, testes.
• ***()ther use includes urology.
• Note 1: Tissue Harmonic Imaging. 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

(Division Sign-Off)

Division of Radiological Devices Vitro Diagnosuc Device Evaluation and Safety Office o n

008-4

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M7/M7T Diagnostic Ultrasound System

i

Transducer: Intended Use:

System:

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

V 10-4Bs

Clinical Application		Mode of Operation
General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	Color Doppler(specify)	CombinedDoppler (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, 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

(Division Sign-Off)
Division of Radiological Devices
Office of la Vitro Dieynestic Device Evaluation and Safe

રાજ્યન

008-5

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M7/M7T Diagnostic Ultrasound System

System: Transducer:

7L4s .

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 (specify)	CombinedDoppler (specify)	Other (specify)
Ophthalmic	Ophthalmic
	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
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 T

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

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

Note8: Amplitude Doppler

Evaluation and Salety

(Divisio Division of Radiological Devices Office വങ്ങ

રાભ

008-6

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M7/M7T Diagnostic Ultrasound System

System: Transducer:

L 14-65

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
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric		P	P	P	P	P	P	Note 1,2, 4,6,7,8
	Small organ(specify)**		P	P	P	P	P	P	Note 1,2, 4,6,7,8
FetalImaging& Other	Neonatal Cephalic		P	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	P	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial		P	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	P	Note 1,2, 4,6,7,8
	Other (specify)

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

N=Hitw mureats: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

Vhune Harts
(Division Sign-Off)

510K

Division ME adiolonical na Office 1910

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

	Diagnostic Ultrasound Indications for Use Form
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 1 Only)	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)**
FetalImaging& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7,8
	Adult Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,7,8
	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
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, 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

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

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

M7/M7T Diagnostic Ultrasound System

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 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	CombinedDoppler (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& Other	Neonatal Cephalic	P	P	P	P	P	P	Note 1, 2,5,6,8
	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
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, 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 I: 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

Kausan thers
(Division Sign-Off)
Division of Radiological Devices

office office office office office office office office office office office office office office office office office office office office office office office office office valuation and Safety

રાભ

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

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 (specify)	CombinedDoppler (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal	P	P	P		P	P	Note1,2, 3, 4,6,8
	Abdominal	P	P	P		P	P	Note 1,2, 3, 4,6,8
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
FetalImaging& Other	Pediatric	P	P	P		P	P	Note1,2, 3, 4,6,8
	Small organ(specify)**
	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	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

M7/M7T Diagnostic Ultrasound System

4CD4s

Transducer:

System:

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

Evaluation and Safety

Note8 Amplitude Doppler

(Division Sign-Off)
Division A Radiological Devices
Office of in Vitro Versio

II

{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	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	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Adult Cephalic	P	P	P		P	P	Note 1, 2, 4,6,7,8
	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)

.

M7/M7T Diagnostic Ultrasound System

6C2s

Transducer:

System:

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 Bign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation

510K

aluzion and Salety

008-11

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

Diagnostic Ultrasound Indications for Use Form M7/M7T Diagnostic Ultrasound System

Transducer: Intended Use:

System:

7L5s 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
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	P	P	P	P	P	P	Note 1,2, 4,6,7,8
	Small organ(specify)**	P	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	P	Note 1,2, 4,6,7,8
	Musculo-skeletal Superficial	P	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	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

Amplitude Doppler

evice Evaluation and Safety

Raune Shaus
(Division Sign-Off)
Division of Radiological Devices

Vitto Diagnos

Office of In:

008-12

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

System:	M7/M7T Diagnostic Ultrasound System
Transducer:	L7-3s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
	Clinical Application
	General(Track 1 Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler (specify)	Combined(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
	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

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

510K

008-13

Diagnostic Ultrasound Indications for Use Form

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

M7/M7T Diagnostic Ultrasound System

System: Transducer:

L12-4s

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 (specify)	CombinedDoppler (specify)	Other (specify)
Ophthalmic	Ophthalmic
	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
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, 4,6,7,8
	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

A - new merballen, a - posted - 3 - 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

Division of Radiological Devices
Office of in Vitro, Diagnostic Device Evaluation and Safety
510K.

008-14

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

System:

Transducer:

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

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound System

L14-6Ns

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

14 tion matean.org + proveed 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 I : 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 Doppier.

SION S Division of Rociological Devicas ામને of In Dia Blustion and Salan

008-15

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

System:	M7/M7T Diagnostic Ultrasound System
Transducer:	P12-4s
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 (specify)	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	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)**
	Neonatal Cephalic	P	P	P	P	P	P	Note 1,2,5,6,8
	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
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	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
	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

1+ hew marcator, 1 - provided yours: 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

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

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

Clinical Application			Mode of Operation
General	Specific(Track I Only) (Track I & 3)	B	M		PWD CWD	Color	CombinedDoppler (specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric				P
FetalImaging& Other	Small organ(specify) **
	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 Adult				P
	Cardiac Pediatric				P
Cardiac	Intravascular (Cardiac)
	Trans-esoph. (Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

M7/M7T Diagnostic Ultrasound System

CW2s

Transducer:

System:

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

N +Color + Browents: 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

svice Evaluation and Safety

Raume Thasur
(Division Sign-Off)
Division of Radiological Devices

Office office office office office office office office office office official official official official official official official official official official official offic

510K

.

.

108-17

{22}------------------------------------------------

M7/M7T Diagnostic Ultrasound System

System: Transducer: Intended Use:

7LT4s 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 (specify)	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal	N	N	N	N	N	N	Note1,2,4,6,7,8
	Intraoperative (specify)*	N	N	N	N	N	N	Note1,2,4,6,7,8
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric	N	N	N	N	N	N	Note1,2,4,6,7,8
	Small organ(specify)**	N	N	N	N	N	N	Note1,2,4,6,7,8
	Neonatal Cephalic	N	N	N	N	N	N	Note1,2,4,6,7,8
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph. (non-Card.)
	Musculo-skeletal Conventional	N	N	N	N	N	N	Note1,2,4,6,7,8
	Musculo-skeletal Superficial	N	N	N	N	N	N	Note1,2,4,6,7,8
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	N	N	N	N	N	N	Note1,2,4,6,7,8
	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

Co Evaluation and Co

Note8: Amplitude Doppler

(Division Sign-Oll)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Selet

Vitro Dieg

008-18

{23}------------------------------------------------

M7/M7T Diagnostic Ultrasound System

System: . Transducer:

P7-3Ts

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 (specify)	Other (specify)
Ophthalmic	Ophthalmic
FetalImaging& Other	Fetal
	Abdominal
	Intraoperative (specify)*
	Intraoperative (Neuro)
	Laparoscopic
	Pediatric
	Small organ(specify)**
	Neonatal Cephalic
	Adult Cephalic
	Trans-rectal
	Trans-vaginal
	Trans-urethral
	Trans-esoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
Cardiac	Cardiac Adult
	Cardiac Pediatric
	Intravascular (Cardiac)
	Trans-esoph.(Cardiac)	N	N	N	N	N	Note 1,2,5,6,8
	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, 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(Rea!-time 3D)

Note 4: iScape

Note5: TDI

Note6: Color M

Note7: Biopsy Guidance

ote8: Amplitude Doppler

Kame Massess
(Division Sign-Off)

gigel Devices Division of Radio o Evaluation and Safety Office Vitro Diagnostie of In

510K

108-19

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.