Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Small Organ, Pediatric, Fetal, Intra-Operative, Transesophageal, Transvaginal, Transrectal, Peripheral Vascular, Neonatal and Adult Cephalic. Cardiac is Adult and Pediatric. Small organ includes breast.

Device Description

Strain Rate Imaging is a modification to the motion analysis capability of the System FiVe / EchoPac. It gives the user the ability to assess the rate of deformation in tissue. When used for cardiac analysis, the user can assess the rate of dimensional changes in the myocardium during the cardiac cycle in a manner similar to tissue velocity imaging. Strain rate can also describe the resistance of tissue objects to external compression.

AI/ML Overview

The provided document does not contain details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in a quantitative sense as typically seen for AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to general safety standards.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not report specific quantitative acceptance criteria or detailed device performance metrics for the Strain Rate Imaging functionality. The evaluation for substantial equivalence primarily relies on non-clinical tests related to safety and general performance of the Doppler technology, and a claim that no clinical tests were required.

Therefore, a table with quantitative acceptance criteria and reported device performance cannot be generated from this document.

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

The document states: "Strain Rate Imaging is implemented with Doppler technology which has undergone testing with phantoms and test objects with known characteristics to assure the accuracy of dimensional and dynamic measurements."

Sample Size for Test Set: Not specified. The phrase "phantoms and test objects" suggests a limited number of controlled, non-human samples.
Data Provenance: Not explicitly stated, but it's in vitro (phantoms and test objects) rather than clinical. It is a non-clinical evaluation.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only mentions "testing with phantoms and test objects with known characteristics," implying that the "ground truth" for these tests was derived from the known characteristics of the phantoms/objects themselves, not expert adjudication of images.

4. Adjudication Method for the Test Set:

Adjudication method: Not applicable/None mentioned. Since the testing was reportedly done on phantoms and test objects with known characteristics, the ground truth would inherently be these known characteristics, not subject to expert adjudication of potentially ambiguous clinical findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No. The document explicitly states: "Clinical Tests: None required." Therefore, no comparative effectiveness study with human readers (with or without AI assistance) was conducted or reported.
Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Was a standalone performance study done? The document describes non-clinical tests on phantoms and test objects "to assure the accuracy of dimensional and dynamic measurements." This constitutes a standalone evaluation of the Strain Rate Imaging technology, but within the context of a general ultrasound system, not as a separate AI algorithm being evaluated for specific clinical performance metrics. The focus is on the accuracy of the Doppler technology to measure strain rate from these objects. No specific metrics like sensitivity, specificity, or AUC are provided for this standalone performance.

7. Type of Ground Truth Used:

Type of Ground Truth: "Known characteristics" of phantoms and test objects. This is an in vitro ground truth for assessing the fundamental measurements of the Doppler technology. It is not expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set:

The document does not mention any training set. This is consistent with devices from this era (1999) that were typically based on conventional signal processing and image reconstruction techniques, rather than machine learning algorithms requiring explicit training data. The device is a modification to existing Doppler technology.

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

Not applicable, as no training set is mentioned in the document.

Summary of Acceptance and Evidence:

The acceptance of the GE Vingmed System FiVe Diagnostic Ultrasound System / EchoPac with Strain Rate Imaging was based on:

Demonstrating substantial equivalence to an existing predicate device (GE Vingmed Ultrasound System FiVe diagnostic ultrasound system / EchoPac, 510(k) Number K963315).
Compliance with applicable medical device safety standards (acoustic output, biocompatibility, thermal, electrical, and mechanical safety).
Non-clinical testing of the Doppler technology using phantoms and test objects with known characteristics to ensure accuracy of dimensional and dynamic measurements.

The key point is that for this device, a 510(k) submission from 1999, the regulatory pathway relied on demonstrating safety and effectiveness by showing it was substantially equivalent to a device already on the market, rather than requiring extensive clinical trials or performance assessments with quantitative acceptance criteria typically associated with modern AI/ML devices.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, creating a strong contrast. The logo is simple, recognizable, and has a classic design.

K991842

GE Vingmed Ultrasound

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

Section a):
1.Submitter:	GE Vingmed Ultrasound A/SP.O. Box 141,N-3191 Horten, Norway
Contact Person:	Paul Fredriksen,Quality Assurance ManagerTelephone: 011-47-3302-1107, Fax: 011-47-3302-1350
Date Prepared:	25 February 1999
2.Device Name:	GE Vingmed System FiVe Diagnostic Ultrasound System / EchoPacwith Strain Rate Imaging Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
3. Marketed Device:	GE Vingmed Ultrasound System FiVe diagnostic ultrasound system /EchoPac, 510(k) Number K963315, currently in commercialdistribution.
4. Device Description:	Strain Rate Imaging is a modification to the motion analysis capabilityof the System FiVe / EchoPac. It gives the user the ability to assess therate of deformation in tissue. When used for cardiac analysis, the usercan assess the rate of dimensional changes in the myocardium duringthe cardiac cycle in a manner similar to tissue velocity imaging. Strainrate can also describe the resistance of tissue objects to externalcompression.
5. Indications for Use:	System FiVe is intended for the following applications: Abdominal,Cardiac, Small Organ, Pediatric, Fetal, Intra-Operative,Transesophageal, Transvaginal, Transrectal, Peripheral Vascular,Neonatal and Adult Cephalic.
6. Comparison with Predicate Device:	The GE Vingmed System FiVe Diagnostic UltrasoundSystem / EchoPac with Strain Rate Imaging is of a comparable typeand substantially equivalent to the currently marketed GE VingmedSystem FiVe / EchoPac. It has the same technological characteristics,is comparable in key safety and effectiveness features, uses the samedesign, construction, and materials, and has the same intended uses,transducers and operating modes as the predicate device.

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are three decorative swirls around the letters, one at the top, one on the left, and one on the right.

Section b):

1. 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. Strain Rate Imaging is implemented with Doppler technology which has undergone testing with phantoms and test objects with known characteristics to assure the accuracy of dimensional and dynamic measurements.
1. 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 & 13485 quality system standards. 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 Vingmed Ultrasound that the System FiVe / EchoPac with Strain Rate Imaging is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Public Health Service

JUN 1 1 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE VingMed Ultrasound A/S C/O Chantel Carson Underwriters Laboratories 333 Pfingsten Road Northbrook, IL 60662-2092

K991842 GE VingMed System FiVe Diagnostic Ultrasound System/ EchoPac with Strain Rate Imaging Dated: May 21, 1999 Received: May 28, 1999 Regulatory Class: II 21 CFR 892.1560, 892.1550 and 892.1570 Procodes: 90 IYO, 90 IYN and 90 ITX

Dear Mr. Carson:

RE:

We have reviewed your Section 510(k) 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 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 also applies to the following transducers intended for use with the VingMed FiVe Diagnostic Ultrasound System as described in your premarket notification:

Transducer Model Number(s):

KG100001/A, KG100001/B, KG100001/C, KK100001/A, KK100001/B, KK100005, KN100001, KN100002/B, KN100003, KN100007/A, KN100007/B, KN100008, KQ100001, KQ100002, KW100001, TE100024, TG100102, TK100104, TN100047, TN100049, TN1000053, TN100065, TN100119, TQ100001, TQ100002 and TT100101

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic QS inspections, the FDA will verify such assumptions.

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

Page -2 - Mr. Carson

Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification does not affect any obligation you may have under sections 531 and 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Please be advised that the determination above is based on the fact that no medical devices have been demonstrated to be safe and effective for in vitro fertilization or percutaneous umbilical blood sampling, nor have any devices been marketed for these uses in interstate commerce prior to May 28, 1976, or reclassified into class I (General Controls) or class II (Special Controls). FDA considers devices specifically intended for in vitro fertilization and percutaneous umbilical blood sampling to be investigational, and subject to the provision of the investigational device exemptions (IDE) regulations, 21 CFR. Part 812. Therefore, your product labeling must be consistent with FDA's position on this use.

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 and additionally 809.10 for in vitro diagnostic devices), 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 807.97). Other general information on vour responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Robert Phillips, Ph.D at (301) 594-1212.

Sincerely yours.

Rate Phillips

CAPT Daniel Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Attachment A

Indications for Use Forms

Diagnostic Ultrasound Indications for Use Form

GE Vingmed System FiVe

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P	P	P	P		P
Abdominal		P	P	P	P	P	P		P
Intraoperative (non-neurological)		P	P	P	P	P	P		P
Intraoperative Neurological
Pediatric
Small Organ (breast)		P	P	P		P	P		P
Neonatal Cephalic		P	P	P	P	P	P		P
Adult Cephalic		P	P	P	P	P	P		P
Cardiac		P	P	P	P	P	P		P
Transesophageal		P	P	P	P	P	P		P
Transrectal		P	P	P		P	P		P
Transvaginal		P	P	P		P	P		P
Transuretheral
Intravascular
Peripheral Vascular		P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

N= new indication; P= previously cleared by FDA; E= added under Appendix E Additional Comments: Cardiac is Adult and Pediatric. Small organ includes breast.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD Cardiac includes cardiac analysis applications

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

Concurrence of CDRH, Office of Device Evaluation (OD

Rat. G. Pauly

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K991842

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

GE Vingmed System FiVe with Probe KG 100001/A

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		P
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

R.C. Parks
(Division Sign-Off)

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

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

GE Vingmed System FiVe with Probe KG 100001/B

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		P	P	P	P	P	P		P
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

FR 801.109)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

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

GE Vingmed System FiVe with Probe KG 100001/C

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic		E	E	E	E	E	E		E
Cardiac		E	E	E	E	E	E		E
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

Rate Pely

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

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

GE Vingmed System FiVe with Probe KK 100001/A

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

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

GE Vingmed System FiVe with Probe KK 100001/B

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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) Rate C. Phelps
(Division, Sign & Stamp)

ign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number

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

GE Vingmed System FiVe with Probe KK 100004

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/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) Rate C. Phillips

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

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

GE Vingmed System FiVe with Probe KK 100005

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		E	E	E	E	E	E		E
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

Rat A. Pules

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

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

GE Vingmed System FiVe with Probe KN 100001

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal		P	P	P	P	P	P		P
Abdominal		P	P	P	P	P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		P	P	P	P	P	P		P
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991842

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

GE Vingmed System FiVe with Probe KN 100002/B

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		E	E	E	E	E	E		E
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic		E	E	E	E	E	E		E
Adult Cephalic
Cardiac		E	E	E	E	E	E		E
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rat-A.Pley

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

Attachment A

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

GE Vingmed System FiVe with Probe KN 100003

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular		P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD

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

Ratc. Pallys
(Division Sign Off) outcome.text,

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

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

GE Vingmed System FiVe with Probe KN 100006

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		E	E	E	E	E	E	E	E
Transesophageal		E	E	E	E	E	E	E	E
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rat C. Phillips
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological L

510(k) Number

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

GE Vingmed System FiVe with Probe KN 100007/A

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

						Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Ra A. Phillips
Division Sign Off

Division Sign-C Division of Reproductive, Abdominal, ENT and Radiological Devi 510(k) Number

Prescription User (Per 21 CFR 801.109)

Attachment A

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

GE Vingmed System FiVe with Probe KN 100007/B

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal	P	P	P	P	P	P	P		P
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rat. A. Pally

Prescription User (Per 21 CFR 801.109)

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

Attachment A

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

GE Vingmed System FiVe with Probe KN 100008

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal		P	P	P		P	P		P
Abdominal		P	P	P		P	P		P
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD

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

Rat A. Phee
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number

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

GE Vingmed System FiVe with Probe KQ 100001

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

Clinical Application	B	M	PWD	ColorDoppler	AmplitudeDoppler	Combined(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD

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

Rat. C. Phelps
Division Sign Off

Prescription User (Per 21 CFR 801.109)

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

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

GE Vingmed System FiVe with Probe KQ 100002

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color Doppler	Amplitude Doppler	Color Velocity Imaging	Combined (specify)	Other (specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal		E	E	E	E	E	E	E	E
Transvaginal		E	E	E	E	E	E	E	E
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD

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

Rate Pally
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi

Prescription User (Per 21 CFR 801.109)

Attachment A

510(k) Number

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

GE Vingmed System FiVe with Probe KW 100001

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (breast)	P	P	P	P		P	P		P
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular	P	P	P	P		P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD

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

Ra E. Phillips
Division Sign-Off

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

Prescription User (Per 21 CFR 801.109)

Attachment A

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

GE Vingmed System FiVe with Probe TE 100024

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac				P	P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

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

Rate Phillips
(Division Sign-Off) Prescription User (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, EN11 and Radiological De 510(k) Number

Attachment A

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

GE Vingmed System FiVe with Probe TG 100102

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Ra. A. Pally
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

{24}------------------------------------------------

GE Vingmed System FiVe with Probe TK 100104

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rat C. Phelps
Division Sign-Off

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Device

510(k) Number K991842

Attachment A

{25}------------------------------------------------

GE Vingmed System FiVe with Probe TN 100047

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal	P	P	P	P	P	P	P		P
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rate Pl
(Division Sign-Off)
Prescription User (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, EN and Radiological D 510(k) Number

{26}------------------------------------------------

GE Vingmed System FiVe with Probe TN 100049

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

Clinical Application	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal		P	P	P	P	P	P		P
Intraoperative (non-neurogical)		P	P	P	P	P	P		P
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

(Division Sign-Off)
Division of Reproductive Abdominal ENT
Prescription User (Per 21 CFR 801.109)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

{27}------------------------------------------------

GE Vingmed System FiVe with Probe TN 100053

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac		P	P	P	P	P	P		P
Transesophageal		P	P	P	P	P	P		P
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Ra.e.Philly
(Division Sign-Off)
Prescription User (Per 21 CFR 801.109)
Dinici
of Ram

Division of Reproductive, Abdominal, ENT, and Radiological I

510(k) Number K991842

{28}------------------------------------------------

GE Vingmed System FiVe with Probe TN 100065

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal		P	P	P	P	P	P		P
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Rat. Pall
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological De

510(k) Number K991842

{29}------------------------------------------------

GE Vingmed System FiVe with Probe TN 100119

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	E	E	E	E	E	E	E		E
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rati Patel

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991842
Pr

{30}------------------------------------------------

GE Vingmed System FiVe with Probe TQ 100001

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify)	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular				E	E
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

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

Rocci Phillips
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological De 510(k) Number

{31}------------------------------------------------

GE Vingmed System FiVe with Probe TQ 100002

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

Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular				E	E
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

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

Rat E. Phillips
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological Devi

510(k) Number

{32}------------------------------------------------

GE Vingmed System FiVe with Probe TT 100101

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

	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(specify	Other(specify)
Ophthalmic
Fetal
Abdominal
Intraoperative (specify)
Intraoperative Neurological
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P		P
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intravascular
Peripheral Vascular	P	P	P	P	P	P	P		P
Laparoscopic
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)

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

Additional Comments: Cardiac is Adult and Pediatric.

Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD

(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)

R.C. Phillips
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Device

510(k) Number K991842

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.