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, an OLED or LCD 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

This document is a 510(k) Premarket Notification submission for the GE Vivid E80, Vivid E90, and Vivid E95 diagnostic ultrasound systems. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices and does not describe a study to establish new acceptance criteria or performance metrics for the core ultrasound imaging functionalities.

Instead, the submission highlights updates and new features compared to the predicate devices and confirms adherence to established safety and performance standards. Therefore, the device doesn't "meet acceptance criteria" in the sense of a novel clinical efficacy study, but rather demonstrates that changes and new features do not negatively impact safety or effectiveness, and that the device continues to conform to existing regulatory and voluntary standards.

Here's a breakdown of the information requested, based on the provided text:

1. Table of acceptance criteria and the reported device performance:

Since this is a submission for substantial equivalence based on updates to a previously cleared device (K173341) and new features, the "acceptance criteria" discussed are primarily compliance with general safety and performance standards and demonstrating that the new features do not compromise this. There are no specific numerical performance metrics for clinical efficacy presented for the overall device in this document, as the core diagnostic ultrasound functionality has been cleared previously.

The document lists compliance with several voluntary standards:

Acceptance Criteria (Compliance with Standards)	Reported Device Performance
ANSI / AAMI ES60601-1 (Medical Electrical Equipment Safety)	Complied
IEC60601-1-2 (Electromagnetic Compatibility)	Complied
IEC60601-2-37 (Ultrasonic Medical Diagnostic Equipment Safety)	Complied
ISO10993-1 (Biological Evaluation of Medical Devices)	Complied (Biocompatibility of materials)
IEC62359 (Thermal and Mechanical Indices of Ultrasonic Fields)	Complied
ISO14971 (Application of risk management)	Complied
NEMA (Digital Imaging and Communications in Medicine - DICOM Set)	Complied (DICOM capability in device description)

For the new features, the "acceptance criteria" are implied to be that they perform as intended and are substantially equivalent to existing functionalities or enhance workflow without impacting safety or effectiveness. The document asserts this by stating:

CT Fusion: "substantially equivalent to the V Nav feature with Fusion on LOGIQ E9 (K082185)."
4D Marker: "an extension of existing image annotation capabilities on the predicate Vivid E90 / Vivid E95 (K173341)."
4D Auto LAO: "substantially equivalent to the 4D Auto RVQ already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
AutoEF 2.0 & AFI 2.0: "workflow improvement of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)." and "expanded ... for pediatric use."
Automatic View Recognition: "workflow improvement to AFI 2.0 and Auto EF 2.0 and provides an automated alternative to manual image selection already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341)."
"Whitelisting", "Texture", "Hybrid Filter", 24" LCD monitor, reduced weight: Explicitly state "no impact on the safety or effectiveness of the clinical functionality" or device.

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 does not detail specific sample sizes or data provenance for a test set in the context of a clinical study for performance evaluation. The submission relies on non-clinical tests and demonstrations of substantial equivalence for feature updates rather than a new clinical performance study.

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)

No information provided. Clinical studies with expert ground truth establishment are not described for this submission.

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

No information provided, as clinical studies with adjudication methods are not described.

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

No MRMC comparative effectiveness study is mentioned in this document. The "Automatic View Recognition" feature uses a deep neural network, but its performance is described as an "automated alternative to manual image selection" and a "workflow improvement" to existing functionalities, rather than a comparative effectiveness study showing human reader improvement with AI assistance.

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

The document mentions "Automatic View Recognition" which is "new functionality based on deep neural network embedded into the software." While this suggests a standalone algorithm, no standalone performance metrics (e.g., sensitivity, specificity) are provided for this feature. Its role is described as a "workflow improvement" and "automated alternative" to manual processes.

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

For the new AI/software features, the "ground truth" seems to be implicitly the functionality of the predicate device or a clinical outcome (e.g., left atrium volumes as measured by the device for "4D Auto LAO"). However, the explicit method of establishing this ground truth (e.g., expert consensus on specific cases for validation) is not detailed in this summary.

8. The sample size for the training set

The document states that "Automatic View Recognition" is "new functionality based on deep neural network." However, it does not provide any information regarding the sample size of the training set used for this deep neural network.

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

The document does not provide any information regarding how the ground truth for the training set was established for the deep neural network used in "Automatic View Recognition."

Summary

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GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226

October 25, 2018

Re: K181685

Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: October 8, 2018 Received: October 9, 2018

Dear Tracey 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image contains a digital signature of Michael D. O'hara-S. It includes the name Michael D. O'hara -S on the left side of the image. The right side of the image contains the digital signature details, including the date 2018.10.25.

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

Enclosure

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Indications for Use

510(k) Number (if known)

K181685

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.

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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.

There are no changes to the Indications for Use compared to the predicate Vivid E95 / Vivid E90 / Vivid E80 (K173341)

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

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Image /page/4/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 has a swirling pattern around the letters, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand's long history and global presence.

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	P	[8]
Transvaginal	P	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]
[4] Other use includes Urology/Prostate
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)

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	[8]
Pediatric	P	P	P		P	P	P	P	P	P	[8]
Small Organ
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
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 ાં 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)

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	Combined HarmonicModes	Imaging	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

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]
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)

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 4V-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	[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]

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)

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Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	Modes	Combined Harmonic CodedImaging	Pulse	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	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]

[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)

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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue. The logo is simple and recognizable, representing the brand identity of General Electric.

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	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	P	[4,8]
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P	P	P	P	P	P		P	[8]
Transvaginal	P	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		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

[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 ાં 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)

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

Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle has a white border with a decorative pattern. The logo is simple and recognizable, and it is associated with a well-known and established 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
Abdominal	P	P	P	P	P	P	P	P	P	P	[1,8,10]
Pediatric	P	P	P	P	P	P	P	P	P	P	[8]
Small Organ (specify)	P	P	P	P	P	P	P	P	P	P	[8]
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	[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	P	[8]
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 ાં 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)

{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 script, enclosed within a circular frame. The logo is colored in blue, with a white outline around the letters and the circular frame.

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

[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 ાં 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)

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

Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	[9]

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 ાં 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)

{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 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 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

[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 ાં 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)

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

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	Combined Modes	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 ાં 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)

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

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	[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

[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 ાં 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)

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

Image /page/16/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 circular border. The logo is colored in blue, with a white outline around the letters and the circular border, providing contrast and definition.

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 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)

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

Image /page/17/Picture/22 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The circle is surrounded by decorative swirls, giving it a classic and recognizable appearance.

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	P	[8]
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]
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	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]
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 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)

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

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined 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 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	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	[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 ાં 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)

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

Image /page/19/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 frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color scheme.

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:

Clinical ApplicationAnatomy/ 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 [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)

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Image /page/20/Picture/0 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 letters are also blue, and there are small white swirls around the perimeter of the circle, adding a sense of motion or energy to the design.

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]
- Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
- [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)

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Image /page/21/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 frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color, which is consistent with GE's branding.

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:

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)

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Image /page/22/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 frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color scheme.

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 ાં 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)

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

Image /page/23/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 frame has decorative swirls or flourishes around the perimeter, giving it a classic or vintage appearance. The logo is presented in a blue color scheme.

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 ાં 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)

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

K181685

Image /page/24/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 in the center. There are water droplet-like shapes surrounding the letters. The logo is simple and recognizable.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	October 5, 2018
Submitter:	GE Medical Systems Ultrasound and Primary Care Diagnostics9900 Innovation DriveWauwatosa, WI 53226
Primary Contact Person:	Tracey OrtizRegulatory Affairs DirectorGE HealthcareT:(262) 676-6120
Secondary Contact Person:	Jan Tore ThollefsenRegulatory Affairs ManagerGE Vingmed Ultrasound AS
Device: Trade Name:Common/Usual Name:Classification Names:	Vivid E80, Vivid E90, Vivid E95Diagnostic Ultrasound SystemClass 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:Secondary PredicateDevice(s):	Vivid E80, Vivid E90, Vivid E95 (K173341)LOGIQ E9 (K082185)
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. Vivid E80will support 2D imaging, while Vivid E90 and Vivid E95 willsupport real time 3D imaging in addition to 2D, and incorporateseveral real-time 3D transducers. Vivid E80 / Vivid E90 / Vivid95 consists of a mobile console with keyboard control panel;color LCD/TFT touch panel, an OLED or LCD 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.

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Image /page/25/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 blue circle. There are three white, water-drop-shaped elements surrounding the circle, positioned at the top, left, and right sides. The logo is simple and iconic, representing the well-known multinational corporation.

Intended Use: 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/Obstetrics; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculoskeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular). The Vivid E80 / Vivid E90 / Vivid E95 employs the same Technology: fundamental scientific technology as its predicate devices. Determination of Comparison to Predicate Devices Substantial Equivalence: The Vivid E80 / Vivid E90 / Vivid E95 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness. . The new feature "CT Fusion" is added as an imaging tool to allow the user to view aligned Computed Tomography and 4D Ultrasound data simultaneously on the Vivid E95 scanner. CT Fusion in Vivid E95 is substantially equivalent to the V Nav feature with Fusion on LOGIQ E9 (K082185). The new feature "4D Marker" allows the user to manually ● place annotations/markers into 3D/4D datasets on Vivid E95, and on Vivid E90 when upgraded to 4D. This is an extension of existing image annotation capabilities on the predicate Vivid E90 / Vivid E95 (K173341). . The new features "4D Auto LAO" is a new feature for quantification of Left Atrium volumes, emptying fraction and strain in live 3D (4D). The feature is substantially equivalent to the 4D Auto RVQ already present on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341). "AutoEF 2.0" is a workflow improvement of functionality ● already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341). ● "AFI 2.0" is a workflow improvement of functionality already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341). In addition to the changes to the tool, we have now expanded if for pediatric use.

{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 a stylized font in the center. There are three white water droplets around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known and established company.

. "Automatic View Recognition" is new functionality based on deep neural network embedded into the software of Vivid E95 / Vivid E90. Automatic View Recognition is a tool for workflow improvement to AFI 2.0 and Auto EF 2.0 and provides an automated alternative to manual image selection already available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341).
With the subject submission references to two new studies for Z-score values are added to the "Z Score" functionality available on the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341).
"Stream Server" functionality is added for streaming 2D and 4D ultrasound data real time over LAN or WLAN network connection, using secure authentication and encryption. The functionality is enabled by the ultrasound operator and is for visualization of ultrasound images to a remote reviewer. The feature is an augmentation of the capabilities of the previously cleared predicate (K173341) allowing remote viewing.
. "Tricefy Uplink" is available with the subject Vivid E80 / Vivid E90 / Vivid E95 enabling a new dataflow to Tricefv Cloud service offered by Trice Imaging Inc.
The software features of the subject Vivid E80 / Vivid E90 ● / Vivid E95 are installed and are running under Windows 10 Embedded Operating software environment. This is substantially equivalent to the cleared Vivid E80 / Vivid E90 / Vivid E95 (K173341) where the software features were installed and were running under Windows 7 Embedded.
"Whitelisting" is implemented on the subject Vivid E80 / ● Vivid E90 / Vivid E95. White listing is a cyber security technology available with Windows 10 Embedded, and is implemented as additional protection against running and infecting the ultrasound system with malware. The addition of "Whitelisting" will have no impact on the safety or effectiveness of the clinical functionality of the Vivid systems.
. "Texture", an imaging technique for enhancement of structural information and attenuation of reverberations, was added. Texture supplements traditional B-Mode imaging and can be toggled on/off from QuickApps control

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

Image /page/27/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are three curved lines emanating from the circle, suggesting movement or energy. The logo is simple and recognizable, and it is associated with a well-known and established company.

510(k) Premarket Notification Submission

panel. Texture has no impact on the safety or effectiveness of the Vivid systems.

"Hybrid Filter", a post processing image algorithm for B-. mode imaging, was added. Hybrid filter is controlled from the control panel and is designed to enhance strong structures in the image without affecting subtle image information. Hybrid Filter has 3 settings Off / Mild / Strong per user preference and has no impact on the safety or effectiveness of the Vivid Systems.
A 24" LCD monitor is added as an alternative to the 22" . OLED monitor cleared with the predicate Vivid E80 / Vivid E90 / Vivid E95 (K173341). The change has no impact on safety or effectiveness of the devices.
The weight of Vivid E80 / Vivid E 90 / Vivid E95 was reduced from 126 Kg to 120 Kg due to re-configuration and re arrangement of internal parts. No functionality was removed, and the reduction has no impact on the safety or effectiveness of the devices.

Summary of Non-Clinical Tests:

Vivid E80 / Vivid E90 / Vivid E95 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 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.
ISO10993-1, Biological Evaluation of Medical Devices-● Part 1: Evaluation and Testing- Third Edition, 2009

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

Image /page/28/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are three curved lines emanating from the circle, suggesting movement or energy. The logo is simple and recognizable, and it is associated with a well-known and established company.

GE Healthcare

510(k) Premarket Notification Submission

IEC62359. Test methods for the determination of thermal ● and mechanical indices related to medical diagnostic ultrasonic fields, 2017
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)

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.

Conclusion: GE Healthcare considers the Vivid E80 / Vivid E90 / Vivid E95 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.