Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Specific clinical uses include cardiac (adult & pediatric); peripheral vascular; transesophageal; abdominal including GYN and urology; fetal; pediatric; small organ including breast, testes, thyroid; adult and neonatal cephalic; intraoperative (abdominal, thoracic, and vascular); musculo-skeletal (conventional and superficial); transvaginal and transrectal.

Device Description

The GE Vivid 3 Pro and Expert are minor variations of the Vivid 3 suited for slightly different market segments. The Expert version provides more features as standard equipment while the Pro version, having fewer base options, allows features to be added if desired. Both systems consists of a mobile console with digital beam former and assorted electronic array transducers. Their user interface consists of a keyboard control panel and color video display monitor. They are network accessible and have integrated on-board image storage and hard-copy devices.

AI/ML Overview

The provided FDA 510(k) summary for the GE Vivid 3 Expert/Pro Diagnostic Ultrasound System does not contain typical acceptance criteria or a study demonstrating device performance in the way a clinical trial or algorithm validation study would.

This document is a premarket notification submission (510(k)) for substantial equivalence, not a detailed performance study report. The key assertion is that the new device (GE Vivid 3 Expert/Pro) is substantially equivalent to a previously cleared predicate device (GE Vivid 3 system, K000695). Therefore, the "acceptance criteria" and "device performance" are primarily focused on matching the predicate device's characteristics and adhering to safety standards.

Here's an analysis based on the provided text, addressing your points as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, there isn't a direct "acceptance criteria vs. reported performance" table in the sense of accuracy, sensitivity, or specificity for diagnostic tasks. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device and compliance with applicable safety standards.

Acceptance Criteria Category	Description/Standard Met	Reported Device Performance
Technological Characteristics	"Same technological characteristics" as predicate device.	The GE Vivid 3 Expert/Pro systems have a mobile console with digital beam former and assorted electronic array transducers, a keyboard control panel, and a color video display monitor. They are network accessible and have integrated on-board image storage and hard-copy devices, consistent with the predicate.
Safety and Effectiveness Features	"Compare in key safety and effectiveness features" to predicate.	Demonstrated to be safe and effective due to substantial equivalence and adherence to safety standards.
Design, Construction, Materials	"Use same design, construction, and materials" as predicate.	Confirmed to be the same as the predicate device.
Intended Uses and Clinical Applications	"Similar intended uses, clinical applications" as predicate.	General purpose ultrasound systems specialized for cardiac imaging, with a broad range of specific clinical uses matching those of the predicate device (Cardiac, Peripheral Vascular, Abdominal, Fetal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Intraoperative, Musculo-skeletal, Transesophageal, Transvaginal, Transrectal, Urology). Many new indications (N) are added for specific transducers, but these are for the same overarching clinical applications.
Operating Modes	"Similar operating modes" as predicate.	Supports B, M, PW Doppler, CW Doppler (for some transducers), Color Doppler, Color M Doppler, Power Doppler, Combined Modes (B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD), and Harmonic Imaging. Some transducers also support Coded Pulse.
Acoustic Output	Conformity with applicable medical device safety standards for acoustic output.	Evaluated, found to conform. (Note: A post-clearance special report for production units was requested to ensure continued compliance.)
Biocompatibility	Conformity with applicable medical device safety standards for biocompatibility.	Evaluated, found to conform.
Thermal, Electrical, Mechanical Safety	Conformity with applicable medical device safety standards.	Evaluated, found to conform.
Quality System Regulation	Compliance with 21 CFR 820 Quality System Regulation.	Manufacturer's design and development process conforms to 21 CFR 820, ISO 9001, & EN 46001.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable (N/A). This submission explicitly states "Clinical Tests: None required." The substantial equivalence determination relies on comparisons to the predicate device and adherence to recognized safety standards, not on a new clinical test set for performance evaluation in the usual sense (e.g., diagnostic accuracy).
Data Provenance: N/A for clinical performance data. The data provenance discussed is related to non-clinical tests (acoustic output, biocompatibility, safety) which would be lab-based testing conducted by the manufacturer (GE Medical Systems).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

N/A. No clinical test set requiring ground truth established by experts was performed or reported in this 510(k) summary.

4. Adjudication Method for the Test Set

N/A. No clinical test set requiring adjudication was performed or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No. This type of study would compare human readers with and without AI assistance to measure a change in diagnostic effectiveness. This 510(k) does not involve AI, nor does it present an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a diagnostic ultrasound system, a medical imaging hardware and software system, not an AI algorithm intended for standalone interpretation. Performance evaluation here refers to the system's ability to produce images and perform measurements, and its safety, in comparison to an existing device.

7. The Type of Ground Truth Used

N/A for clinical performance in a diagnostic sense. For the non-clinical tests (acoustic output, safety, etc.), the "ground truth" would be established by physical measurements against established industry standards and regulatory limits.

8. The Sample Size for the Training Set

N/A. This submission is for an ultrasound system, not an AI/ML algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

N/A. As there is no AI/ML algorithm involved requiring a training set, the concept of establishing ground truth for a training set does not apply here.

In summary: This 510(k) submission for the GE Vivid 3 Expert/Pro Diagnostic Ultrasound System is a demonstration of substantial equivalence to a predicate device, focusing on similar technological characteristics, intended uses, safety, and compliance with general device regulations and standards. It is not an AI/ML device, and therefore does not include detailed clinical performance studies in the way you might expect for an algorithm seeking FDA clearance, nor does it involve test sets, training sets, or expert ground truthing for AI performance metrics.

Summary

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K020789

Section 2: 510(k) Summarv Per 21 CFR Part 807.92.

APR 0 4 2002

GE Medical Systems

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,

Manager, Safety and Regulatory Engineering Telephone: 414-647-4385, Fax: 414-647-4090

March 8, 2002 Date Prepared:

GE Vivid 3 Expert/Pro Diagnostic Ultrasound System. 2. Device Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN

Marketed Device: GE Vivid 3 Expert/Pro is substantially equivalent to the GE Vivid 3 system, 510(k) Number K000695, a device currently in commercial distribution.
Device Description: The GE Vivid 3 Pro and Expert are minor variations of the Vivid 3 suited for slightly different market segments. The Expert version provides more features as standard equipment while the Pro version, having fewer base options, allows features to be added if desired. Both systems consists of a mobile console with digital beam former and assorted electronic array transducers. Their user interface consists of a keyboard control panel and color video display monitor. They are network accessible and have integrated on-board image storage and hard-copy devices.
Indications for Use: The GE Vivid 3 Expert/Pro systems are general purpose ultrasound systems that are specialized for cardiac imaging. Specific clinical uses include cardiac (adult & pediatric); peripheral vascular; transesophageal; abdominal including GYN and urology; fetal; pediatric; small organ including breast, testes, thyroid; adult and neonatal cephalic; intraoperative (abdominal, thoracic, and vascular); musculo-skeletal (conventional and superficial); transvaginal and transrectal.
Comparison with Predicate Device: The GE Vivid 3 Expert/Pro systems are of comparable type and substantially equivalent to the GE Vivid 3. They have the same technological characteristics, compare in key safety and effectiveness features, use same design, construction, and materials, and have similar intended uses, clinical applications, transducers and operating modes as the predicate devices.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & EN 46001 quality system standards for medical device manufacturers. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing production surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Vivid 3 Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administra 9200 Corporate Boulevard Rockville MD 20850

Mr. •Allen Schuh Manager GE Ultrasound Product Safety and Regulatory Compliance GE Medical Systems P.O. Box 414 MILWAUKEE WI 53201

APR 0 4 2002

Re: K020789

Trade Name: GE Vivid 3 Expert/Pro Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: 90 IYO Dated: March 8, 2002 Received: March 11, 2002

Dear Mr. Schuh:

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 GE Vivid 3 Expert/Pro Diagnostic Ultrasound Systems, as described in your premarket notification:

Transducer Model Number

E721 Transducer i12L Transducer

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Page 2 - Mr. Schuh

i8L Transducer
i13L Transducer
i739 or t739 Transducer
7L Transducer
12L Transducer
5S Transducer
10S Transducer
6T Transducer
8T Transducer
P6D Transducer
P509 Transducer
358C Transducer
10L Transducer
3S Transducer
7S Transducer
5T Transducer
P2D Transducer

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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.

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

The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.

Sincerely yours,

David A. Syron

Nancy C. Brogdon ir Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro Ultrasound System

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal [1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	P	P	P	E
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac [3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	E
Musculo-skeletal Conventional	P	P	P		P		P	P	E
Musculo-skeletal Superficial	P	P	P		P		P	P	E
Other [4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal	N	N	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N	N	N
Transuretheral
Intraoperative (specify)[5]	P	P	P		P		P	P	E
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jamil U. Kazmi

{5}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with E721 Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	Color Doppler	Power Doppler	Combined Modes	Harmonic Imaging
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N	N	N	N	N
Transvaginal	N	N	N	N	N	N	N
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[4] Other use includes Urology.

[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Higginson

(Division Sig Division of Re and Rad 510(k) Nur

{6}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with i12L Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N
Small Organ (specify)[2]	N	N	N	N	N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N
Musculo-skeletal Conventional	N	N	N	N	N	N	N
Musculo-skeletal Superficial	N	N	N	N	N	N	N
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	N	N	N	N	N	N	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Hynson

(Division Sign-Off Division of Reproduc and Radiological De 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with i8L Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	N	N	N		N		N	N	N
Peripheral Vascular	N	N	N		N		N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	N	N	N		N		N	N	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

Thrist A. Stinson

(Division Sign-Off Division of Reproduc and Radiological De 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with i13L Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	N	N	N	N	N		N	N	N
Peripheral Vascular	N	N	N	N	N		N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	N	N	N	N	N		N	N	N
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off) Division of Reproductive. and Radiological Devi 510(k) Numb

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with i739 or t739 Transducers

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E		E		E	E	E
Pediatric
Small Organ (specify) [2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	E	E	E		E		E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	E	E	E		E		E	E	E
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

David G. Syborn

(Division Sign-Off) Division of Reproductive, A and Radiologi 510(k) Numb

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 7L Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	E	E	E		E		E	E	E
Small Organ (specify)[2]	E	E	E		E		E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular	E	E	E		E		E	E	E
Musculo-skeletal Conventional	E	E	E		E		E	E	E
Musculo-skeletal Superficial	E	E	E		E		E	E	E
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[2] Omail organ molades broad, 100.00, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elvin H. Syverson

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 12L Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric	E	E	E				E	E	E
Small Organ (specify)[2]	E	E	E				E	E	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E				E	E	E
Musculo-skeletal Conventional	E	E	E				E	E	E
Musculo-skeletal Superficial	E	E	E				E	E	E
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	E	E	E				E	E	E
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [2] Small organ includes breast, testes, thyroid.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

(Division Sign-Off) Division of Reproductive and Radiological Dev 510(k) Number

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 5S Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	E	E	E	E	E	E	E	E	E
Abdominal[1]	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[0] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription User (Per 21 CFR 801.109)

David G. Nystrom

(Division Sign-Off) Division of Reproductive. and Radiological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 10S Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E
Small Organ (specify)[2]
Neonatal Cephalic	E	E	E	E	E	E	E	E	E
Adult Cephalic	E	E	E	E	E	E	E	E	E
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Jarrid A. Myrum

(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 6T Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	E	E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number __

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 8T Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal	E	E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[0] Combined modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Hepburn

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with P6D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			E	E
Peripheral Vascular			E	E
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

$ 13.1

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with P509 Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal	E	E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: {3} Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 358C Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	E
Abdominal[1]	P	P	P		P		P	P	E
Pediatric	P	P	P		P		P	P	E
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
I anarosconic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehrnid A. Lephorn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number .

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use For

GE Vivid 3 Expert/Pro with 10L Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	E
Abdominal[1]
Pediatric	P	P	P	P	P	P	E
Small Organ (specify)[2]	P	P	P	P	P	P	E
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	E
Musculo-skeletal Conventional	P	P	P	P	P	P	E
Musculo-skeletal Superficial	P	P	P	P	P	P	E
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	E
Intraoperative Neurological
Intravascular

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

Notes: [2] Small organ includes breast, testes, thyroid.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

[0] Mitraoporative modes are B/M, B/PWD, B/Color/PWD, B/Amplitude/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Dupont

(Division Sign-Off) Division of Reproductive, Abde and Radiological Devices 510(k) Number

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 3S Transducer

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

Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[+] Othor use inforded orelogy.
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seymour

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Devices 510(k) Number __

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 7S Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[4] Other use includes orblog?
[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David C. Bergman

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with 5T Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

(Division Sign-Off) Division of Reproductive, Abdom and Radiological Dev S ! Victorial

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Vivid 3 Expert/Pro with P2D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[*] Combined modes are B/M, B/PWD, B/CWD, B/Color/PWD, B/Amplitude/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Heatman

(Division Sign-Off) Division of Reproductive. and Radiological Devi 510(k) Number

Prescription User (Per 21 CFR 801.109)

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.