Vivid E80 / Vivid E90 / Vivid E95 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrios; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vasculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Description

Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3 diagnostic ultrasound systems primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / Vivid E90 / Vivid E95 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers. Vivid E80 will support 2D imaging, while Vivid E90 and Vivid E95 will support real time 3D imaging in addition to 2D, and incorporate several real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid 95 consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, OLED color video display, DVI connector for optional external video display, and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the manner one might find in a full clinical trial report for novel technologies.

Based on the provided text, the device itself is a diagnostic ultrasound system (Vivid E80, Vivid E90, Vivid E95) and the acceptance criteria and study information are presented in the context of demonstrating substantial equivalence to a predicate device (Vivid E80, Vivid E90, Vivid E95 (K170823)).

Here's the breakdown of the requested information based on the provided document:

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

The document does not provide a specific table of quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) and corresponding reported performance values from a dedicated clinical study for the entire device. Instead, it states that the device complies with voluntary standards for safety and performance (summarized below). The "performance" reported is primarily in terms of equivalency to the predicate device and the added capabilities.

Acceptance Criterion (Implied/Standard)	Reported Device Performance
Safety and Effectiveness	Substantially equivalent to the predicate device(s).
Acoustic Output	Evaluated and complies with applicable medical device safety standards.
Biocompatibility	Evaluated and complies with applicable medical device safety standards. Transducer materials and other patient contact materials are biocompatible.
Cleaning and Disinfection Effectiveness	Evaluated and complies with applicable medical device safety standards.
Thermal Safety	Evaluated and complies with applicable medical device safety standards.
Electrical Safety	Evaluated and complies with applicable medical device safety standards.
Electromagnetic Safety	Evaluated and complies with applicable medical device safety standards (IEC60601-1-2).
Mechanical Safety	Evaluated and complies with applicable medical device safety standards.
Compliance with Voluntary Standards	ANSI / AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, IEC62359, ISO14971, NEMA DICOM Set.
Functional Equivalence (with predicate)	Same fundamental scientific technology, intended use, imaging capabilities, technological characteristics.
New Transducer Features	4Vc-D: Reduced physical dimensions and weight compared to predicate 4V-D, identical indications for use.10T-D: Same indications for use as predicate 9T transducer.
New Option Feature	Vmax: Higher processing speed (GPU) enabling higher 4D volume-rates in imaging.

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

The document explicitly states: "The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence." This means no clinical "test set" in the traditional sense of patient data was used for this 510(k) submission. The evaluation was based on non-clinical tests (bench testing, engineering verification).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical studies were required, there were no "experts" establishing ground truth in the context of a clinical test set. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device and the demonstration that the modified device (including new transducers and GPU option) does not raise new questions of safety or effectiveness.

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

Not applicable, as no clinical test set requiring ground truth adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an ultrasound system (hardware and software), not an AI-assisted diagnostic tool in the sense of providing interpretations that would be evaluated in an MRMC study for reader improvement.

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

Not applicable. As above, this is a diagnostic ultrasound imaging system, not a standalone algorithm.

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

Not applicable, as no clinical studies were required and the submission relies on non-clinical testing and substantial equivalence to a predicate device. The "ground truth" here is compliance with recognized safety and performance standards for ultrasound equipment.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device that undergoes training on a dataset. The device is a diagnostic ultrasound system.

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

Not applicable, as this is not an AI/ML device that undergoes training on a dataset.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health & Human Services logo features a stylized human figure with three faces in profile, representing the department's focus on people's health and well-being. The FDA acronym is in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

November 2, 2017

Re: K173341

Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 24, 2017 Received: October 25, 2017

Dear Ms. Ortiz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K173341

Device Name Vivid E80 Vivid E90 Vivid E95

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid E80, Vivid E90 and Vivid E95. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.

The following Indication for Use forms are appended:

System: Vivid E80 / Vivid E90 / Vivid E95 Transducer: C3-10-D Transducer: 12S-D Transducer: 4V-D Transducer: 4Vc-D Transducer: iC5-9-D Transducer: 8C Transducer: C2-9-D Transducer: 9L-D Transducer: 11L-D Transducer: M5Sc-D Transducer: 6S-D Transducer: C1-6-D Transducer: L8-18i-D Transducer: 6VT-D Transducer: 6Tc Transducer: 6Tc-RS Transducer: 9T Transducer: 9T-RS Transducer: 10T-D Transducer: P2D Transducer: P6D

{4}------------------------------------------------

Image /page/4/Picture/1 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 that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form Vivid E80 / Vivid E90 / Vivid E95 Ultrasound System

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[6,8,9,11]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,6,8,9,10]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6,8,9]
Small Organ	P	P	P	P	P	P	P	P	P	P	[2,8]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[8,9]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[6,9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,6,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[8]
Other	P	P	P	P	P	P	P	P	P	P	[4,6,8,9]
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P	[6,9]
Transrectal	P	P	P	P	P	P	P	P		P	[8]
Transvaginal	P	P	P	P	P	P	P	P		P	[8]
Transuretheral
Intraoperative	P	P	P	P	P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8,9]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

Small organ includes breast, testes, thyroid [2]
Cardiac is Adult and Pediatric [3]
Other use includes Urology/Prostate [4]
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
Includes image guidance for freehand needle placement [7]

Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

ləl Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/5/Picture/1 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 that has decorative, swirling elements around it. The logo is presented in a blue color scheme.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C3-10-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	P	P	P	P	[8]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV. PICC)	P	P	P	P	P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a double border, with the inner border being a slightly lighter shade of blue. There are decorative white swirls around the letters, adding a touch of elegance to the design.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 12S-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	P	P	P	P	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/7/Picture/1 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, and the entire logo is rendered in a light blue color. The logo is simple, recognizable, and represents the General Electric brand.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4V-D Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[6,9,11]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6,9]
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[6,9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,6,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology/Prostate

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

3D/4D Imaging mode [6]

[7] Includes image guidance for freehand needle placement

Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/8/Picture/1 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 that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4Vc-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	N	N	N	N	N	N	N	N	N	N	[6,9,11]
Abdominal	N	N	N	N	N	N	N	N	N	N	[1,6,9]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6,9]
Small Organ
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N	[6,9]
Cardiac	N	N	N	N	N	N	N	N	N	N	[3,6,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	N	N	N	N	N	N	N	N	N	N	[4,6,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	N	N	N	N	N	N	N	N	N	N	[9]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement

Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with iC5-9-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P	[8,11]
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P		P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P	P	P	P		P	[8]
Transvaginal	P	P	P		P	P	P	P		P	[8]
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P		P	[7,8]
Vascular Access (IV, PICC)	P	P	P		P	P	P	P		P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/10/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. The letters are also blue and have a swirling design. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 8C Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics											[1,8,10]
Abdominal	P	P	P		P	P	P	P	P	P	[1,8,10]
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ (specify)	P	P	P		P	P	P	P	P	P	[8]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P	P	P	[8]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/11/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the long-standing brand identity of General Electric.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C2-9-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P		P	P	P	P	P	P	[8,11]
Abdominal	P	P	P		P	P	P	P	P	P	[1,8,10]
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P		P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/12/Picture/1 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 that has decorative, swirling elements around it. The logo is presented in a blue color scheme.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9L-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P		P	P	P	P	P	P	[8]
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ	P	P	P		P	P	P	P	P	P	[2,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P	P	P	[7,8]
Vascular Access (IV. PICC)	P	P	P		P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/13/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the outside of the circle, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 11L-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ	P	P	P		P	P	P	P	P	P	[2,8]
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P	P	P	[7,8]
Vascular Access (IV, PICC)	P	P	P		P	P	P	P	P	P	[8]

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/14/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative swirls around the outside of the circle, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with M5Sc-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Modes	Combined HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[9,11]
Abdominal	P	P	P	P	P	P	P	P	P	P	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	[9]
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[9]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,9]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[9]
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid

[3] Cardiac is Adult and Pediatric

[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]

Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl

[10] Abdominal includes Aorta-Iliac Artery

[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/15/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6S-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[9,11]
Abdominal	P	P	P	P	P	P	P	P	P	P	[9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[9]
Small Organ
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	P	[9]
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	P	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid
- [3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
- 3D/4D Imaging mode [6]
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

GE Healthcare

Image /page/16/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, and the circle has a double border, also in blue.

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C1-6-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P	P	[8,11]
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,8]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[8]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other	P	P	P	P	P	P	P	P	P	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P	P	P	P	P	P	P	P	[7,8]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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)
[6] 3D/4D Imaging mode
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

GE Healthcare

Image /page/17/Picture/1 description: The image shows the General Electric (GE) logo. The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle has a decorative border with curved lines. The logo is simple and recognizable, representing the well-known multinational conglomerate.

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with L8-18i-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ	P	P	P		P	P	P	P	P	P	[2,8]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P	[8]
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[8]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[8]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P		P	P	P	P	P	P	[5,8]
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy	P	P	P		P	P	P	P	P	P	[7,8]
Vascular Access (IV. PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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)
[6] 3D/4D Imaging mode
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ાં છો
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/18/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative, swirling pattern, also in blue, which gives the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6VT-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/ Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[6,9]
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	P	[6,9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid
- [3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]

3D/4D Imaging mode [6]

[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/19/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Surrounding the circle are decorative, swirling lines, giving the impression of motion or energy.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 6Tc/6Tc-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	Combined HarmonicModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[9]
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	P	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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
- ાંકી Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
- [11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/20/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative swirls, also in blue, giving the logo a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9T/9T-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	[3,9]
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	P	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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
- ાંકી Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
- [11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/21/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by a series of curved, white lines that resemble water droplets or stylized leaves, giving the logo a distinctive and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 10T-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/ Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	N	N	N	N	N	N	N	N	N	N	[3,9]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other (specify)
Exam Type, Means of Access
Transesophageal	N	N	N	N	N	N	N	N	N	N	[9]
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Interventional Guidance
Tissue Biopsy
Vascular Access (IV, PICC)

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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
- ાંકી Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD 81
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
- [11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/22/Picture/1 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, and the entire logo is rendered in a light blue color. The logo is simple, recognizable, and represents the General Electric brand.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with P2D Transducer

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

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

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid
- [3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV [5]
- 3D/4D Imaging mode [6]
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/23/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls around its perimeter, giving it a classic and recognizable appearance.

Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with P6D Transducer

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

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

P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication

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

[2] Small organ includes breast, testes, thyroid
- [3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
- 3D/4D Imaging mode [6]
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

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

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

Image /page/24/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are in a stylized font, and there are decorative swirls around the circle. The logo is simple and recognizable, and it is associated with a well-known company.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	October 23, 2017
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262)676-6120F:(414)918-8275
Secondary Contact Person:	Jan Tore ThollefsenRegulatory Affairs ManagerGE Vingmed Ultrasound AS
Device: Trade Name:	Vivid E80, Vivid E90, Vivid E95
Common/Usual Name:	Diagnostic Ultrasound System
Classification Names:	Class II
Product Code:	Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Primary Predicate Device:	Vivid E80, Vivid E90, Vivid E95 (K170823)
Device Description:	Vivid E80 / Vivid E90 / Vivid E95 systems are Track 3diagnostic ultrasound systems primarily intended for cardiacimaging and analysis, but which also includes vascular andgeneral radiology applications. The Vivid E80 / Vivid E90 /Vivid E95 incorporates a variety of electronic array transducersoperating in linear, curved linear, sector/phased array or matrixarray format, including two dedicated CW transducers. VividE80 will support 2D imaging, while Vivid E90 and Vivid E95will support real time 3D imaging in addition to 2D, andincorporate several real-time 3D transducers. Vivid E80 / VividE90 / Vivid 95 consists of a mobile console with keyboardcontrol panel; color LCD/TFT touch panel, OLED color videodisplay, DVI connector for optional external video display, andoptional image storage and printing devices. It provides highperformance ultrasound imaging and analysis and hascomprehensive networking and DICOM capability.
Intended Use:	Vivid E80 / Vivid E90 / Vivid E95 is a general-purposeultrasound system, specialized for use in cardiac imaging. It isintended for use by, or under the direction of a qualifiedphysician for ultrasound imaging and analysis ofFetal/Obstetrics; Abdominal (including renal and GYN);Pediatric; Small Organ (breast, testes, thyroid); NeonatalCephalic; Adult Cephalic; Cardiac (adult and pediatric);Peripheral Vascular (PV); Musculo-skeletal Conventional;Musculo-skeletal Superficial; Urology (including prostate),Transesophageal; Transrectal (TR); Transvaginal (TV); andIntraoperative (abdominal, thoracic, & vascular).
Technology:	The Vivid E80 / Vivid E90 / Vivid E95 employs the samefundamental scientific technology as its predicate devices.
Determination ofSubstantial Equivalence:	Comparison to Predicate DevicesThe Vivid E80 / Vivid E90 / Vivid E95 systems are substantiallyequivalent to the predicate devices with regard to intended use,imaging capabilities, technological characteristics and safety andeffectiveness.
	A new transducer, "4Vc-D", was added for use withregular 2D and 4D imaging. The 4Vc-D is a matrix arraytransducer which is built on design principles from thepredicate 4V-D, already cleared for use with Vivid E80,Vivid E90 and Vivid E95 (K170823). 4Vc-D has reducedphysical dimensions and weight compared to the predicate4V-D, and has identical indications for use.A new transducer, "10T-D", was added for use withtransesophageal pediatric or adult imaging. 10T-D hasthe same indications for use as the predicate 9Ttransducer already cleared with Vivid E80, Vivid E90

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

Image /page/25/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the letters, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.

and Vivid E95 (K170823).

. A new "Vmax" option was added to offer a high performance Graphical Processing Unit (GPU) as an alternative to the standard GPU used in the predicate Vivid E80 / Vivid E90 / Vivid E95. This new GPU will provide a higher processing speed of the receiving ultrasound information, and thus enable higher 4D volume-rates in imaging.

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

Image /page/26/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and the circle has a wavy border. The logo is simple and recognizable, and it is associated with a well-known company.

Vivid E80 / Vivid E90 / Vivid E95 has been evaluated for acoustic Summary of Non-Clinical output, biocompatibility, cleaning and disinfection effectiveness Tests: as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Vivid E80 / Vivid E90 / Vivid E95 complies with voluntary standards:

. ANSI / AAMI ES60601-1. Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005/A1:2012
. IEC60601-1-2, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007.
IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007-08.
NEMA UD 3, Standard for Real Time Display of ● Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 2004
ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009
IEC62359, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010
ISO14971. Application of risk management to medical devices. 2007
. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2016

The following quality assurance measures were applied to the development of the system:

Risk Analysis
Usability Analysis ●
Requirements Reviews ●
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use testing (Validation) ●

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

Image /page/27/Picture/0 description: The image shows the logo of General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, wave-like patterns, also in blue, giving the logo a dynamic and recognizable appearance.

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests: The subject of this premarket submission, Vivid E80 / Vivid E90 / Vivid E95, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Vivid E80 / Vivid E90 / Vivid E95 Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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.