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 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

The provided text is a 510(k) summary for the Shenzhen Mindray Bio-medical Electronics Co., LTD M7/M7T Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than providing a detailed study proving performance against specific acceptance criteria for an AI/algorithm-driven device.

Therefore, many of the requested details regarding acceptance criteria, study performance, sample sizes, ground truth establishment, expert adjudication, and comparative effectiveness studies are not present in this type of regulatory submission for a diagnostic ultrasound system.

Here's an analysis of what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not provide specific acceptance criteria or quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm. Instead, it asserts that the device has been "evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety" and "found to conform with applicable medical safety standards." It lists several IEC and ISO standards that the device is designed to meet.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. The submission describes a general-purpose diagnostic ultrasound system, not an AI/algorithm with a test set of data. The "tests" mentioned are non-clinical safety and performance tests for hardware and basic functionality.

3. 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. No ground truth establishment for a diagnostic algorithm is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method for a test set is described.

5. 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 a submission for a diagnostic ultrasound system, not an AI-assisted diagnostic tool. The "Q-view software" and "Q-path" mentioned are for digital image storage and remote access, not for AI assistance in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is an ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Not applicable. No ground truth is described in the context of an AI/algorithm for diagnostic performance. The ground truth for evaluating the safety and performance mentioned would be established by standard engineering and medical device testing methodologies.

8. The sample size for the training set:

Not applicable. There is no mention of a "training set" as this is not an AI/algorithm submission.

9. How the ground truth for the training set was established:

Not applicable.

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: K131690

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

Date Prepared: May 23, 2013

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 (90-1YN) 21 CFR 892.1560 Ultrasonic Pulsed Echo Imaging System (90-1YO) 21 CFR 892.1570 Diagnostic Ultrasound Transducer (90-ITX)

Image /page/0/Picture/14 description: The image shows the text '003 1' in a bold, sans-serif font. The numbers are aligned horizontally, with a slight gap between '003' and '1'. There is an underscore between the 3 and the 1. The background is plain white, providing a clear contrast for the black text.

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3. Device Description:

4. Intended Use:

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/M7T	K121010

The only difference between the subject device and the predicate device is that the Q-view software had been installed to the subject device to enable Q-path. Q-path is a network server provided by Telexy Healthcare Inc. for digital image storage. Q-view is a client viewing tool for the server. Telexy Healthcare developed technology and a command structure that allows any Q-view enabled ultrasound system to access Q-path directly from the ultrasound system using a single control. The primary purpose for Q-view is to provide remote access to O-path from the ultrasound system, eliminating the necessity to log in to Q-path from a separate workstation.

The subject device and the predicate device have the same technological characteristics.

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and they are comparable in key safety and effectiveness features, and have the same intended uses and basic operating modes.

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

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.

B-3

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's emblem in the center. The emblem is a stylized representation of a bird or eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 24, 2013

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

Re: K131690

Trade/Device Name: M7/M7T Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: 1YN, 1YO, and ITX Dated: July 15, 2013 Received: July 17, 2013

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.

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

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Page 2 - Yang Zhaohui

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

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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/McdicalDeyices/Safety/ReportaProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosures

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Indications for Use

510(k) Number (if known): K131690

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 transesophageal (cardiac) exams.

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$m:7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K131690 510(k)

Page 1 of 1

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Transducer:	N/A
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application			Mode of Operation
GeneralSpecific(Track 1 Only) (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)*	P	P	P		P	P	Note 1,2,4,6,7,8
	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	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	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	P	P	P	P	P	P	Note 1,2,4,5,6,7,8
	Musculo-skeletal Superficial	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)	P	P	P	P	P	P	Note 1,2,5,6,8
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular	P	P	P		P	P	Note 1, 2, 4,6,7,8
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Transducer:

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, lestes.

***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 Health Office of In Vitro Diagnostics and Radiological Health 510(k)

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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 I Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
	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-csoph.(non-Card.)
	Musculo-skeletal Conventional
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult
Cardiac	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)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound 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-lime 3D), Note 4: iScape; Note5: TDI

Note6: Color M; Note7: Biopsy Guidance: Note8: Amplitude Doppler

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131690

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Transducer:				V10-4s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
GeneralSpecific(Track 1 Only) (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) **
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	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)

M7/M7T Diagnostic Ultrasound System

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, Power + PW +B.

*Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, lestes.

***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-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k) K 131690

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Transducer:	V10-4Bs
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
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)

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

M/M/1 Diagnostic Ultrasound

Nenew indication; P=previously cleared by FDA: E=added under Appendix E

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

Intraoperative includes abdominal, thoracic, and vascular.

**Small organ-breast, thyroid, iestes

·**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: NoteS: TDI

Note6: Color M. Note7: Biopsy Guidance: Note8: Amplitude Doppler

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131690

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

Transducer:	71.4s
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	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)**	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)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound System

Nonew 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: NoteS: TDI

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Transducer:	L14-65
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	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)

M7/M7T Diagnostic Ultrasound System

System:

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

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 Health Office of In Vitro Diagnostics and Radiological Health KJ31690 510(k)

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

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	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
	Other (specify)

M7/M7T Diagnostic Ultrasound System

System: Tr હતા.

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, lestes.

•••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 Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131690

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

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	Combined(specify)	Other (specify)
Ophthalmic	Ophthalmic
	Fetal
FetalImaging& Other	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	P	P	P	P	P	P	Note 1, 2.5,6.8
	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)

Diagnostic Ultrasound Indications for Use Form

M7/M71" Diagnostic Ultrasound 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 I: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D: Note 3:4D(Real-lime 3D); Note 4: iScape; Note5: TDI

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k) K 131690

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

	Diagnostic Ultrasound Indications for Use Form
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	Specific				CW	Color	Combined
	(Track 1 Only)	B	M	PWD	D	Doppler	(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)**
Fetal	Neonatal Cephalic
Imaging	Adult Cephalic
& Other	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)

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 3:40(Real-lime 3D); Note 4: iScape; Note5: TDI

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131690

e lu

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

Mindray Co. Ltd.- M7/M7T Diagnostic Ultrasound System

System:

Transducer:	6C2s
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	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, 4,6,7,8
	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)

Diagnostic Ultrasound Indications for Use Form

M7M7T Diagnostic Ultrasound 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, Power + PW +B,

Intraoperative includes ubdominal, 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 Health Office of In Vitro Diagnostics and Radiological Health 510(k) K 131690

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

71.5s Transducer: Intended Use Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application CW Color Combined General Specific PWD B M Other (specify) (Track I Only) (Track | & 3) D Doppler (specify) Ophthalmic Ophthalmic Fetal Abdominal Intraoperative (specify)* Intraoperative (Neuro) Laparoscopic P P Note 1,2, 4,6,7,8 Pediatric P P P Small organ(specify)** P P P P P Note 1,2, 4.6,7,8 Neonatal Cephalic Fetal lmaging Adulı Cephalic & Other Trans-rectal Trans-vaginal Trans-urethral Trans-esoph. (non-Card.) p P Note 1,2, 4,6,7,8 P Musculo-skeletal Conventional P P P Note 1,2, 4,6,7,8 Musculo-skelctal Superficial ♪ P P b Intravascular Other (specify) *** Cardisc Adult Cardiac Pediatric Cardiac Intravascular (Cardiac) Trans-esoph.(Cardiac) Intra-Cardiac P Note 1,2, 4,6,7,8 P P p Peripheral Peripheral Vascular P Vascular Other (specify)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound System

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 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 Health Office of In Vitro Diagnostics and Radiological Health 210(k) K 131690

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

Transducer:	1.7-3s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General(Track I Only)	Specific(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
	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 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)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound 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, Power + PW+B.

*Intraoperative includes abdominal, thoracic, and vasculur.

**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: TD1

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K 131690

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

Clinical Application		Mode of Operation
Specific(Track I Only)(Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
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
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 Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph (Cardiac)
Intra-Cardiac
Peripheral Vascular	P	P	P		P	P	Note 1,2, 4,6,7,8
Other (specify)

M7/M7T Diagnostic Ultrasound System

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

Note 2: Smart3D: Note 3:40(Real-time 3D): Note 4: iScape: Note5: TDI

Note6: Color M: Note7: Biopsy Guidance: Note8: Amplitude Doppler

(Division Sign-ON) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K 131690

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

System:	M7/M7T Diagnostic Ultrasound System
	Transducer:	1.14-6Ns
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	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 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, 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-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health K131690 510(k) _

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

Transducer:			P12-4s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation

SpecificGeneral(Track 1 Only) (Track 1 & 3)		B	M	PWD	CWD	ColorDoppler	Combined(specify)	Other (specify)
	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
	Musculo-skeletal Superficial
	Intravascular
	Other (specify)***
	Cardiac Adult	P	P	P	P	P	P	Note 1, 2,5,6,8
Cardiac	Cardiac Pediatric	P	P	P	P	P	P	Note 1, 2,5,6,8
	Intravascular (Cardiac)
	Trans-esoph (Cardiac)
	Intra-Cardiac
Peripheral	Peripheral Vascular
Vascular	Other (specify)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound System

N=new indicution; P=previously cleared by I·DA; 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; NoteS: TDI

Note6: Color M: Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K131690

06 Te

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

System:	M7/M7T Diagnostic Ultrasound System
Transducer:	CW2s
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
	Small organ(specify)**
Fetal	Neonatal Cephalic
Imaging& Other	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
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 I Tissue Harmonic Imaging The leature does not use contrast agents

Note 2: Smart3D. Note 3.4D(Real-time 3D); Note 4 1Scape. Notes TIXI

Note6: Color M. Note7. Biopsy Guidance: Note8: Amplitude Doppler

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 510(k) K 131690

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

Transducer:				7LT4s
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows.
	Clinical Application		Mode of Operation
General(Track I Only)	Specific(Track I & 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)*	P	P	P		P	P	Note 1,2,4,6,7,8
	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
Fetal	Neonatal Cephalic	P	P	P		P	P	Note 1,2,4,6,7,8
Imaging	Adult Cephalic
& Other	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
Peripheral	Peripheral Vascular	P	P	P		P	P	Note 1,2,4,6,7,8
Vascular	Other (specify)

Diagnostic Ultrasound Indications for Use Form

M7/M7T Diagnostic Ultrasound 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 I: Tissue Harmonic Imaging. The feature does not use contrast agents.

Note 2: Smart3D; Note 3:4D(Real-lime 3D); Note 4: iScape; Note5: TDI

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 210(k) K131690

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

Transducer:				P7-3Ts
Intended Use:	Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application		Mode of Operation
General	Specific(Track I Only) (Track 1 & 3)	B	M	PWD	CWD	ColorDoppler	Combined(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)	P	P	P	P	P	P	Note 1,2,5,6,8
	Intra-Cardiac
PeripheralVascular	Peripheral Vascular
	Other (specify)

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

97 2Ta

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: iScope; Notes: TDI

Note6: Color M; Note7: Biopsy Guidance; Note8: Amplitude Doppler

Smith)

(Division Sign-OM) Division of Radiological Health Office of In Vitro Diagnostics and Radiologica! Health . 510(k) _______________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.