Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description of the EchoPilot software mentions comparing data to guidelines and identifying inconsistencies, which sounds like rule-based logic or expert systems, not necessarily AI/ML. There are no explicit mentions of AI, ML, or related terms like DNN.

Therapeutic

No
The device is described as an ultrasound system intended for "ultrasound evaluation" and "imaging," which are diagnostic purposes, not therapeutic ones. The EchoPilot software also aids in diagnostic reporting.

Diagnostic

Yes

The "Intended Use / Indications for Use" states that the device is for "ultrasound evaluation" of various anatomical sites, which is a diagnostic activity. Additionally, the "Predicate Device(s)" section explicitly mentions "Diagnostic Ultrasound Systems."

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Vivid i and Vivid q are "mobile ultrasound consoles having a wide assortment of electronic array transducers," indicating the presence of hardware components beyond just software. While it mentions "EchoPilot reporting software," this is described as an included component of the larger hardware system.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
Device Function: The description clearly states that this device is a mobile ultrasound console used for ultrasound evaluation of various anatomical sites. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
Intended Use: The intended use describes diagnostic imaging procedures performed directly on the patient, not on in vitro samples.
EchoPilot Software: While the EchoPilot software provides analysis and reporting, it is based on the ultrasound imaging data and user-entered clinical data, not on laboratory test results from biological samples.

Therefore, the device's function and intended use fall under the category of diagnostic imaging devices, not In Vitro Diagnostics.

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/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

Product codes

IYN, IYO, ITX, LLZ

Device Description

The Vivid i and Vivid q are mobile ultrasound consoles having a wid assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Indicated Patient Age Range

Adult and Pediatric

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)

Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been been found to conform with applicable medical device safety standards. The modified Vivid i/q and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final Acceptance Testing (Validation)
Performance testing (Verification)
Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:
The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s)

Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388; Vivid E9 Diagnostic Ultrasound System, K101149

Reference Device(s)

SoundStar eco 10F Transducer, K112050

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.

Summary

0

k |21062

AUG 1 7 2012

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	5 April 2012
Submitter:	GE Healthcare
9900 Innovation Dr
Wauwatosa, WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Manager
GE Healthcare,
T:(414)721-4214
F:(414)918-8275
Secondary Contact Person:	Carmel Lehrer
Regulatory Affairs Specialist
GE Medical Systems Israel Ltd.
T:+972-4-8419-534
F:+972-4-8419-500
Device: Trade Name:	Vivid i and Vivid q Diagnostic Ultrasound System
Common/Usual Name:	Vivid i, Vivid q
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Picture Archiving and Communication System, 21 CFR 892.2050, 90-LLZ
Predicate Device(s):	Vivid i and Vivid q Diagnostic Ultrasound Systems, K102388.
Vivid E9 Diagnostic Ultrasound System, K101149.
Device Description:	The Vivid i and Vivid q are mobile ultrasound consoles having a wid assortment of electronic array transducers intended primarily for echocardiography with additional capability in vascular and general ultrasound imaging. Its intuitive user interface, high level of auto-optimization along with significantly reduced size and weight make it readily maneuverable, efficient and easy to use.
Intended Use:	The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics; Abdominal/Gynecology; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular)

1

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

Technology: The modified Vivid i/q employs the same fundamental scientific technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards. The modified Vivid i/q and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

· Risk Analysis
· Requirements Reviews
· Design Reviews
· Testing on unit level (Module verification)
· Integration testing (System verification)
· Final Acceptance Testing (Validation)
· Performance testing (Verification)
· Safety testing (Verification)

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, the modified Vivid i/q, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the modified Vivid i/q to be as safe, and effective as the predicate device(s). The performance of the modified Vivid i/q is substantially equivalent to the predicate device(s).

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 systems. The device conforms 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.

2

Therefore, it is the opinion of GE Healthcare that the Vivid i/q Diagnostic Ultrasound is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

GE Medical Systems Israel Ltd. % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAWATOSA WI 53226

AUG 1 7 2012

Re: K121062

Trade/Device Name: Vivid i/q Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX, and LLZ Dated: August 10, 2012 Received: August 13, 2012

Dear Mr. Behn:

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 Vivid S5/S6, as described in your premarket notification:

Transducer Model Number

3S-RS	8C-RS
3Sc-RS	E8C-RS
5S-RS	3C-RS
6S-RS	8L-RS
7S-RS	9L-RS
10S-RS	12L-RS
12S-RS	i12L-RS
M4S-RS	6Tc-RS
4C-RS	6T-RS

4

9T-RS	AcuNav TM 8F
P2D	SoundStar 3D 10F
P6D	SoundStar eco10F
AcuNav TM 10F

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Joshua Nipper at (301) 796-6524.

Sincerely Yours,

ichal D'Ohm for

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

Enclosure(s)

5

510(k) Number (if known): K121062

Device Name: Vivid i/q

Indications for Use:

The Vivid i/q ultrasound systems are intended for use by, or under the direction of, a qualified physician for ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

Prescription Use X Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mhald. D. Shene

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

510(k) Number K121062

6

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form Vivid i and Vivid q Diagnostic 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	Other
Ophthalmic	P	P	P	P	P	P	P	P	P	P
Fetal/Obstetrics	P	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P		P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P
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
Transvaginal	P	P	P		P	P	P	P	P	P
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal	P	P	P	P	P	P		P	P
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[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/Color M, B/PWD, B/Color/PWD, B/Power/PWD,

or digitally encoded harmonics.

(Division Sign-Off)
Division of Radiological Devices

510

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

7

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The letters are stylized and connected in a flowing, cursive-like manner. The logo is presented in black and white, with the letters and the frame appearing in black against a white background.

April 5, 2012

Vivid i/q Ultrasound System

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with 3S-RS 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	P
Abdominal [1]	P	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac [2]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

Coded Pulse is for digitally encoded harmonics.

(Division Sign-Off)
Division of Radiological Devices

510k

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8

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circular border. The letters and the border are in black, contrasting with the white background.

GE Vivid i/q with 3Sc-RS 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	E	E	E	E	E	E	E	E	E	E
Abdominal [1]	E	E	E	E	E	E	E	E	E	E
Pediatric	E	E	E	E	E	E	E	E	E	E
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	E	E	E	E	E	E	E	E	E	E
Cardiac [2]	E	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

is for digitally encoded harmonics. ded

(Division Sign-Off)
Division of Radiological Devices

510k

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

9

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background. There are small white dots around the frame.

GE Vivid-i/q with 5S-RS 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
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P		P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Cardiac is Adult and Pediatric.

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

[1] Coded Pulse is for digitally encoded harmonics.

(Division Sign-Off)

0177

SIOK

of Radiological Devices

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

10

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, and the entire logo is presented in black against a white background.

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with 6S-RS 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	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[2]

                               | P                 | P | P             | P             | P                | P                  | P                | P                  | P                   |                 |       |

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

gis Adult and Pediatric.

ed modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.

s for urgittally encoded harmonics.

Division Signdiological Devices

510K

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

11

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined in a stylized, cursive font. The letters are white and set against a solid black circular background. The logo is surrounded by a white border.

GE Vivid i/q with 7S-RS 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	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[2]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

(Division Sign-Off)
Division of Radiological Devices

Elok

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

12

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

GE Vivid i/q with 10S-RS 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
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	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[2]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

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Prescription Use (Per 21 CFR 801.109)

Division of Radiological Devices

13

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, and the background is white.

GE Vivid i/q with 12S-RS 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
Abdominal[1]	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N
Small Organ (specify)
Neonatal Cephalic	N	N	N	N	N	N	N	N	N
Adult Cephalic
Cardiac[2]	N	N	N	N	N	N	N	N	N
Peripheral Vascular	N	N	N	N	N	N	N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

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adiological Devices 10k

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Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, while the background is white. The logo has a classic and recognizable design.

GE Vivid i/q with M4S-RS 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	CW
Doppler 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	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac(2)	P	P	P	P	P	P		P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeleta! Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Cardiac is Adult and Pediatric.

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

[] Coded Pulse is for digitally encoded harmonics.

h DDhm
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of Radiological Devices

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Image /page/15/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 outside of the circle.

GE Vivid i/q with 4C-RS 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
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[2]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Qther use includes Urology.

ombined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Color/PWD, B/Power/PWD.

ded Pulse is for digitally encoded harmonics.

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Division of Radiological Devices
K12062
ok

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Prescription Use (Per 21 CFR 801.109)

で

16

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are white and are set against a solid black circular background. A thin white line borders the black circle.

GE Vivid i/q with 8C-RS 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
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	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

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

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

oded Pulse is for digitally encoded harmonics.

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Division of Radiological Devices
K12062

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Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular frame. The logo is black and white, with the letters and the frame appearing in black against a white background. The design is simple yet recognizable, representing the brand identity of General Electric.

..

510(k) Premarket Notification Submission Vivid i/q Ultrasound System April 5, 2012

Diagnostic Ultrasound Indications for Use Form

Vivid i/q with E8C-RS 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
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other [2]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

[2] Other use includes Urology.

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

yed Pulse is for digitally encoded harmonics.

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Division of Radiological Devices
510k

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18

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are white, and the background is black.

GE Vivid-i/q with 3C-RS 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	P
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[2]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

ther use includes Urology.

(2) o of moined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,

ear of the is for digitally encoded harmonics.

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Division of Radiological Devices
510k K121082 OIVD

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Image /page/19/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, while the background is white.

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with 8L-RS 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
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	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.

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

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

geded Pulse is for digitally encoded harmonics.

510k D Coded Pulse is f

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Klal082OWD

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20

Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters and the circle are black, while the background is white.

Vivid i/q with 9L-RS 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
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	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Abdominal includes GYN/Pelvic and Renal.
[2] Small organ includes breast, testes, thyroid.
[1] Ombined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,
ded Pulse is for digitally encoded harmonics.

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Division of Radiological Devices
510k K121062
OIVD

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Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, creating a recognizable and iconic symbol.

GE Vivid-i/q with 12L-RS 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
Abdominal	P^	P^	P^	P^	N	P^	P^	P^	P^
Pediatric	P•	P•	P•	P•	P•	P•	P•	P•	P•
Small Organ (specify)[1]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

N = new indication; P = previously cleared by FDA; P = previously cleared by FDA (K102393); E = added under Appendix E P = Previously Cleared by FDA (K113690)

Notes:

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

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

Pulse is for digitally encoded harmonics.

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Division of Radiological Devices

210k

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22

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. There are three decorative swirls or flourishes placed around the circle, adding a touch of elegance to the design.

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with i12L-RS 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
Abdominal[1]	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[4]	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

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Division of Radiological Devices

k

[1] Abdominal includes GYN/Pelvic and Renal.

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

[3] Cardiac is Adult and Pediatric.

(4) Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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Image /page/23/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, creating a strong contrast.

Diagnostic Ultrasound Indications for Use Form

Vivid i/q with 6Tc-RS 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac(1)	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes rdjac is Adult and Pediatric. bined modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD. ad Ruise is for digitally encoded harmonics. (Division Siar -Off) vision of Radiological Devices (Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

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r

510k

24

Image /page/24/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. There are two small swirls on the top left and right of the circle.

Diagnostic Ultrasound Indications for Use Form

Vivid i/q with 6T-RS 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[1]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:

[1] Cardiac is Adult and Pediatric.

[*] �ombined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD,

Soped Pulse is for digitally encoded harmonics.

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Division of Radiological Devices

10k

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Image /page/25/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, creating a strong contrast. The logo is simple and recognizable.

510(k) Premarket Notification Submission April 5, 2012 Vivid i/q Ultrasound System

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with 9T-RS 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:
[1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.

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10k
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26

Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters and the circle are in black, creating a strong contrast.

GE Vivid i/q with P2D 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes: [1] Cardiac is Adult and Pediatric.

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510k

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Image /page/27/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape that has a swirling pattern around the perimeter. The logo is black and white.

GE Vivid i/q with P6D 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac{1}				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal
Laparoscopic

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

Notes:
[1] Cardiac is Adult and Pediatric.

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Division of Radiological Devices
510k K121062

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Image /page/28/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white.

Diagnostic Ultrasound Indications for Use Form GE Vivid i/q with AcuNav™ 10F Transducer

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

| Clinical Application

Anatomy/Region of Interest	Mode of Operation
	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[1]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[2]	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P
Laparoscopic

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

Notes:

[1] Cardiac is Adult and Pediatric.

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

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

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diological Devices 510K

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Image /page/29/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The letters and the circle are in white, set against a black background.

April 5, 2012

Diagnostic Ultrasound Indications for Use Form

GE Vivid i/q with AcuNav™ 8F 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [1]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal	P	P	P	P	P	P	P	P	P
Laparoscopic

[1]: N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

Notes
[1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.

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510k Klaloma
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Image /page/30/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, creating a bold and recognizable design.

GE Vivid i/q with SoundStar 3D 10F Transducer

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

| Clinical Application

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

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

Notes:
(1) Cardiacis Adult and Pediatric.
(II) Combined modes are B/M, B/C
IPM Adult Size Off

are B/M, B/Color M, B/PWD, B/CWD, B/Color/PWD, B/Power/PWD.

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Division of Radiological De
510k

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Image /page/31/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are black, creating a strong contrast. The logo is simple, recognizable, and represents the General Electric brand.

Diagnostic Ultrasound Indications for Use Form GE Vivid i/g with SoundStar eco 10F 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
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[1]	E	E	E	E	E	E	E	E	E
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intracardiac and Intraluminal	E	E	E	E	E	E	E	E	E
Laparoscopic

N = new indication (previously cleared as stand-alone medical devices by Biosense Webster, Inc. K112050);

P = previously cleared by FDA; E = added under Appendix E

Notes:

[1] Cardiac is Adult and Pediatric.

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

Andrew D. Ohm
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Radiological Devices 510k

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