GE VIVID 7 BT04

• K Number: K041552
• Device Name: GE VIVID 7 BT04
• Manufacturer: GENERAL ELECTRIC CO.
• Date Cleared: 2004-07-02 ( 23 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal (Conventional, Superficial); Ophthalmic; Transesophageal; Transrectal (TR); Transvaginal (TV); Transuretheral; Intraoperative (abdominal, thoracic, & vascular); Intraoperative Neurological; Intravascular; Laparoscopic; Other (Urology/Prostate).

Device Description

The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis System. It consists of a console approximately 65 cm wide, 96 cm deep and 139 cm high that provided image processing and display capability. The user interface includes a keyboard, trackball, and a color video CRT display. This modification will provide users with enhanced ability to evaluate wall motion during echocardiography.

Predicate Devices

K003931, K031663

Reference Devices

K003931,K031663

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard ultrasound system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No
The device is described as a "Diagnostic ultrasound imaging or fluid flow analysis" system, indicating its purpose is for diagnosis, not therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body." The "Device Description" also refers to it as "The GE Vivid 7 Diagnostic Ultrasound."

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical console with hardware components like a keyboard, trackball, and CRT display, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• Intended Use: The intended use clearly states "Diagnostic ultrasound imaging or fluid flow analysis of the human body". This describes a device that interacts directly with the patient's body to produce images or analyze physiological processes.
• Device Description: The description details a "Diagnostic Ultrasound" system with a console, user interface, and imaging capabilities. This aligns with in-vivo imaging, not in-vitro testing.
• Input Imaging Modality: The input modalities are "Ultrasonic Pulsed Echo Imaging System" and "Ultrasonic Pulsed Doppler Imaging System". These are methods used for imaging within the body.
• Anatomical Site: The extensive list of anatomical sites indicates the device is used to examine various parts of the human body directly.
• IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.

This device does not examine specimens derived from the human body in vitro. It is an in-vivo imaging device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal (Conventional, Additional, Superficial); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Product codes

90-IYO, 90-IYN, 90-ITX

Device Description

The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging console approximately 65 cm wide, 96 cm deep and 139 cm high. The GE Vivid 7 provides imaging, processing and display capability. The user interface includes a trackball, a user-selectable menu that provides alphanumeric and graphical display and a color video CRT display. This modification will provide users with enhanced ability to evaluate wall motion during echocardiography.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasonic Pulsed Echo Imaging System, Ultrasonic Pulsed Doppler Imaging System

Anatomical Site

Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal (Conventional, Additional, Superficial); Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular). Urology/Prostate.

Indicated Patient Age Range

Not Found (explicitly mentioned as "Adult and Pediatric" for Cardiac applications, and "Fetal", "Pediatric", and "Neonatal Cephalic" for other applications)

Intended User / Care Setting

qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection, and patient information safety. The system has been evaluated for thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
Clinical Tests: None required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

GE Vivid 7 Diagnostic Ultrasound System K003931/K031663

Reference Device(s)

GE Voluson 730, GE LOGIQ 9

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

KD41552

JUL 0 2 2004

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/5 description: The image contains the GE logo and the text "GE Medical Systems" on the top right. Below the logo and text, there is a line. Under the line, the text "General Electric Company P.O. Box 414, Milwaukee, WI 53201" is present. The text provides the company's name and address.

Section a):

| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC
PO Box 414, Milwaukee, WI 53201 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,
Manager, Safety and Regulatory Engineering
Telephone: [phone]; Fax: [phone] |
| Date Prepared: | June 8, 2004 |
| 2. Device Name: | GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT04
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |

GE Vivid 7 Diagnostic Ultrasound System K003931/K031663 (90-IYO/IYN/ITX) 3. Marketed Device: A device currently in commercial distribution.

4. Device Description: The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging 4. Device Describitor. The OLE viva PBiag console approximately 65 cm wide, 96 cm deep and 139 cm and analysis System: it ocheloto or a mocessing and display capability. The user interface includes a mgn that provided angler and a color video CRT display. This modification will provide users with enhanced ability to evaluate wall motion during echocardiography.

5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal of Feat, Addit Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Oephane, Addit Ocondio, State), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

6. Comparison with Predicate Device: The GE Vivid 7 BT04 is of a comparable type and substantially equivalent to the current GE Vivid 7 with added features equivalent to the GE Voluson 730, GE LOGIQ 9 equivalence the carrent and the same technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has the same intended uses and basic operating modes as the predicate devices.

Section b):

1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and 1. Normanical colo. The Getto has seen one as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

3. Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA o. "Other and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device manforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory 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 7 BT04 Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.

JUL 02 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Engineering GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue WEST MILWAUKEE WI 53219

Re: K041552

Trade Name: GE Vivid 7 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: June 8, 2004 Received: June 9, 2004

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 7 Ultrasound System, as described in your premarket notification:

2

Transducer Model Number

3.5C	32
		II 9T
ജില്ലാ	is in the many in the minutes of the minutes of the minutes of the minutes of the many of the minutes of the minutes of the minutes of the minutes of the many of the start of	P2D
M7C	108	P6D
기를	M3S	i8L
10L	E8C	गाँउ ह
12L		3V
MI2L	그 기자 (기자)

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.

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.

3

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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 [phone].

Sincerely yours,

Nancy C Brogdon

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

Enclosure(s)

4

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 Ultrasound System

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
Ophthalmic	P	P	P	P	P	P	P	P	P	P	N
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	N
Abdominal[1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ[2]	P	P	P	P	P	P	P	P	N	P	N
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	N
Adult Cephalic	P	P	P	P	P	P	P	P	P	N	N
Cardiac[3]	P	P	P	P	P	P	P	P	P	N	N
Peripheral Vascular	P	P	P	P	P	P	P	P	N	P	N
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	N	P	N
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	N	P	N
Other[4]	P	P	P	P	P	P	P	P	P	P	N
Exam Type, Means of Access	P	P	P	P	P	P	P	P	P	P	N
Transesophageal	P	P	P	P	P	P	P	P	P	P	N
Transrectal	P	P	P	P	P	P	P	P	P	P	N
Transvaginal	P	P	P	P	P	P	P	P	P	P	N
Transuretheral	P	P	P	P	P	P	P	P	P	P	N
Intraoperative[5]	P	P	P	P	P	P	P	P	P	P	N
Intraoperative Neurological	P	P	P	P	P	P	P	P	P	P	N
Intravascular	P	P	P	P	P	P	P	P	P	P	N
Laparoscopic	P	P	P	P	P	P	P	P	P	P	N

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

Notes: [1] Abdominal includes renal, GYN/Pelvic

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

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

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition;

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Sign-C Division of Reproduc and Radiological Devi 510(k) Number

5

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 3.5C Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N	N		N	N	N	N	N	N
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)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

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

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

Nancy C. Broadous

(Division Division of Reproductive and Radiological Devic 510(k) Number

6

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 5C Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	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)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P		P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N	N	N	N	N	N		N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[4] Other use includes Urology;

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

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

Nancy Broadon

(Division Sigr Division of Reproduct and Radiological Devi 510(k) Number

7

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 8C Transducer

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

| Clinical Application
Anatomy/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] | P | P | P | | P | P | P | P | | P | |
| Pediatric | P | P | P | | P | P | P | P | | P | |
| Small Organ (specify) | P | P | P | | P | P | P | P | | P | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | | P | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon
(Division Sign-off)

(Division Sic Division of Reproductive and Radiological Devic 510(k) Number

8

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with M7C Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	P	P	P		P	P	P	P	N	P
Abdominal[1]	P	P	P		P	P	P	P	N	P
Pediatric	P	P	P		P	P	P	P	N	P
Small Organ (specify)	P	P	P		P	P	P	P	N	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	N	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N	N	N	N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[4] Other use includes Urology;

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

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

Nancy Brandon

(Division Sign-C Division of Reproductive, A and Radiological Device 510(k) Number

9

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 7L Transducer

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

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

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

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

Nancy C. Brogdon
(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number _

10

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 10L Transducer

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

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

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

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

Nancy C Broadon

(Division S Division of Reproductive ano Radiological Devices 510(k) Number _

11

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 12L Transducer

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

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

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

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

Nancy Hodgson

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

12

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with M12L Transducer

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

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

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

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

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

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

Nancy C. Brosdon
(Division Sign-Off)

Division of Reproductive, A and Radiological Devices 510(k) Number _

13

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 3S Transducer

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

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	N
Abdominal[1]	P	P	P	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	P	P	P	N
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	N
Cardiac (3)	P	P	P	P	P	P	P	P	P	N
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other 41	P	P	P	P	P	P	P	P	P	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
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;

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

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

Nancy Brogdon

Division Sian-C Division of Reproductiv and Radiological Devices 5 1 ()(k) Number

14

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 5S Transducer

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

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

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

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

Nancy C. Srodon

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

15

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 7S Transducer

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

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

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

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

Vancy C. Broydon

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

16

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 10S Transducer

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

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

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

Nancy C. Brogdon

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

17

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with M3S Transducer

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

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

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

Notes: [1] Abdominal includes Renal and GYN;

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology;

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

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

Nancy C. Hogdon

(Division S Division of Reproductive, Ab and Radiological Devic 510(k) Number

Prescription User (Per 21 CFR 801.109)

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18

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with E8C Transducer

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

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

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

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

Nancy C. Hogdon
(Division Sign-Off)

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

19

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 6T Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Nancy Chroydon

(Division Sign-Off) Division of Reproductive. Abdominat and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

20

Diagnostic Ultrasound Indications for Use Form

GE Vivid 7 with 7T Transducer

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

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

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

Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Nancy Hogdon

(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 7 with 8T Transducer

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

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

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

Nancy C. Brogdon

n of Reproductive Aningical Device ි ! ' ' :