Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System

• K Number: K150087
• Device Name: Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
• Manufacturer: GE VINGMED ULTRASOUND AS
• Date Cleared: 2015-03-04 ( 48 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device 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, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

Device Description

GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / 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 and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

Predicate Devices

K1315141 GE Vivid E9 Diagnostic Ultrasound System, K142323 GE Vivid S60/S70 Diagnostic Ultrasound System, K142160 L8-18i-D Diagnostic Ultrasound Transducer on Logiq E9.

Reference Devices

K1315141, K142323, K142160

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, and the description focuses on traditional ultrasound technology and features.

Therapeutic

No
The device is described as a "general-purpose ultrasound system" and "diagnostic ultrasound system" intended for "ultrasound imaging and analysis," which implies a diagnostic rather than therapeutic function.

Diagnostic

Yes

The "Device Description" explicitly states, "GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system." The "Intended Use" also mentions it is for "ultrasound imaging and analysis."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console with keyboard control panel, touch panel, video display, and optional image storage and printing devices, which are hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states that this device is a diagnostic ultrasound system. Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
• Intended Use: The intended use describes imaging and analysis of various anatomical sites within the body, not the analysis of biological samples.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device 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, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

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

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E80 / E90 / 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 and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, Alternative OLED or LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

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

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal

Intended User / Care Setting

Qualified physician

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

Not Found

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

Not Found

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

The device has been evaluated for acoustic output safety, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Vivid E80 / E90 / E95 and its applications comply with voluntary standards.
The subject of this premarket submission, Vivid E80 / E90 / E95, did not require clinical studies to support substantial equivalence.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K1315141 GE Vivid E9 Diagnostic Ultrasound System, K142323 GE Vivid S60/S70 Diagnostic Ultrasound System, K142160 L8-18i-D Diagnostic Ultrasound Transducer on Logiq E9.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2015

GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Drive, RP-2138 WAUWATOSA WI 53226

Re: K150087

Trade/Device Name: Vivid E90, Vivid E90 and Vivid E95 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: January 13, 2015 Received: January 15, 2015

Dear Mr. Behn:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

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

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K150087

Device Name Vivid E80 and Vivid E90 and Vivid E95

Indications for Use (Describe)

The device 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, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate); Transesophagea1; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

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

[e-mail]

"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, cursive font, enclosed within a circular border. The color of the logo is blue, and the background is white. The logo is simple and recognizable.

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

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

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

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

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)

Prescription User (Per 21 CFR 801.109)

Page 2 of 18

4

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border that resembles a stylized wave or ribbon pattern.

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:

| Clinical Application
Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | RT3D
Mode * | |
|----------------------------------------------------|-------------------|---|---|---|---|---|---|---|---|---|----------------|--|
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Small Organ | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[1] | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [1] Cardiac is Adult and Pediatric.

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

[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 3 of 18

5

Image /page/5/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 decorative border. The logo is simple and recognizable, and it is associated with a well-known company.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

[2] Cardiac is Adult and Pediatric.

[3] Other use includes Urology/Prostate

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

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 4 of 18

6

Image /page/6/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 circular frame. The color of the logo is a light blue.

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

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [4] Other use includes Urology/Prostate;

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

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 5 of 18

7

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The script is white, creating a contrast against the blue background.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

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

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 6 of 18

8

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with a swirling pattern.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

[4] Other use includes Urology/Prostate;

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

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

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

Prescription User (Per 21 CFR 801.109)

Page 7 of 18

9

Image /page/9/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 inside. The letters are white and have a flowing, interconnected design. The circle is surrounded by a decorative border, also in blue, that resembles a series of stylized waves or flourishes.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

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

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 8 of 18

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 letters are white and have a swirling design around them. The logo is simple and recognizable, and it is often used to represent the company's brand.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

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

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

[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 9 of 18

11

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border that resembles a stylized wave or ribbon pattern.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

[ ◆ ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 10 of 18

12

Image /page/12/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 inside. The letters are white and have a flowing, interconnected design. The circle is surrounded by a decorative border, also in blue, that resembles a series of stylized waves or flourishes.

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

P = previously cleared by FDA on Vivid E9 (K131514)

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

[3] Cardiac is Adult and Pediatric.

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

[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 11 of 18

13

Image /page/13/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 a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and associated with a well-known multinational corporation.

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

P = previously cleared by FDA on Vivid S60/S70 (K142323)

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

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

[4] Other use includes Urology/Prostate

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

[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 12 of 18

14

Image /page/14/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 a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and associated with a well-known multinational corporation.

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

P = previously cleared by FDA on Logiq E9 (K142160)

Notes: [1] Abdominal includes Renal, GYN/Pelvic.

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

[4] Other use includes Urology/Prostate

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

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

[ ♦] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 13 of 18

Diagnostic Ultrasound Indications for Use Form

15

Image /page/15/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 there are curved lines around the letters. The logo is simple and recognizable.

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 Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	P
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	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 14 of 18

16

Image /page/16/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 letters are also blue, and they are surrounded by a swirling design. The logo is simple and recognizable, and it is a symbol of the company's long history and its commitment to innovation.

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 Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Harmonic
Modes	Imaging	Coded
Pulse	RT3D
Mode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac	P	P	P	P	P	P	P	P	P	P	P
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	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 15 of 18

17

Image /page/17/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 decorative border. The logo is simple and recognizable, and it is associated with a well-known company.

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 Application
Anatomy/ Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes	Harmonic
Imaging	Coded
Pulse	RT3D
Mode*
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P	P
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	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Laparoscopic

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [3] Cardiac is Adult & Pediatric

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 16 of 18

18

Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The script is white, creating a contrast against the blue background.

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:

| Clinical Application

Anatomy/ Region of Interest	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined Modes	Harmonic Imaging	Coded
Pulse	RT3D
Mode
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
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
Laparoscopic

P = previously cleared by FDA on Vivid E9 (K131514)

Notes: [3] Cardiac is Adult and Pediatric.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 17 of 18

19

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The circle has a decorative border with a swirling pattern.

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:

| Clinical Application

Anatomy/ Region of Interest	Mode of Operation
	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Modes	Combined Harmonic
Imaging	Coded
Pulse	RT3D
Mode
Ophthalmic
Fetal / Obstetrics
Abdominal
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac [3]			P	P
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
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);

(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)

Prescription User (Per 21 CFR 801.109)

Page 18 of 18

20

Image /page/20/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 blue circle. The letters are also blue, matching the color of the circle.

510(k) Summary

| | In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: January 13, 2015 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare, GE Vingmed Ultrasound AS
Strandpromenaden 45
N-3191, Horten, Norway |
| Primary Contact Person: | Bryan Behn
Regulatory Affairs Manager
GE Healthcare, GE Medical Systems Ultrasound and Primary
Care Diagnostics, LLC.
T:[phone]
F:[phone] |
| Secondary Contact Person: | Jan Tore Thollefsen
Regulatory Affairs Manager
GE Vingmed Ultrasound AS
T:([phone]
F:([phone] |
| Device:
Trade Name: | Vivid E80, Vivid E90, Vivid E95 Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid E80, Vivid E90, Vivid E95 |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K1315141 GE Vivid E9 Diagnostic Ultrasound System
K142323 GE Vivid S60/S70 Diagnostic Ultrasound System
K142160 L8-18i-D Diagnostic Ultrasound Transducer on Logiq
E9. |
| Device Description: | GE Vivid E80 / E90 / E95 is a Track 3 diagnostic ultrasound
system, which is primarily intended for cardiac imaging and
analysis, but which also includes vascular and general radiology
applications. The Vivid E80 / E90 / 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 and several real time 3D transducers. It
consists of a mobile console with keyboard control panel; color
LCD/TFT touch panel, Alternative OLED or LCD color video
display and optional image storage and printing devices. It
provides high performance ultrasound imaging and analysis and
has comprehensive networking and DICOM capability. |

21

Image /page/21/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 a decorative, swirling pattern, also in blue. The logo is simple, recognizable, and represents the General Electric brand.

• GE Vivid E80 / E90 / E95 ultrasound system is a general-purpose Intended Use: 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); Musculo-Conventional; Urology (including prostate), skeletal Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
  The Vivid E80 / E90 / E95 employ the same fundamental Technology: scientific technology as its predicate devices.

Determination of Comparison to predicate Substantial Equivalence:

The Vivid E80/E90/E95 systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

| | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
|-----------------------------------------------------|--------------------------------------|----------------------------------------|
| Indications and Clinical Applications: | | |
| ● Fetal/Obstetrics; | ✓ | ✓ |
| ● Abdominal (Including Renal & Gyn) | ✓ | ✓ |
| ● Pediatric | ✓ | ✓ |
| ● Small Organ (breast, testes, thyroid); | ✓ | ✓ |
| ● Neonatal Cephalic; | ✓ | ✓ |
| ● Adult Cephalic; | ✓ | ✓ |
| ● Cardiac (adult and pediatric); | ✓ | ✓ |
| ● Peripheral Vascular; | ✓ | ✓ |
| ● Musculo-skeletal Conventional | ✓ | ✓ |
| ● Urology (including prostate); | ✓ | ✓ |
| ● Transesophageal; | ✓ | ✓ |
| ● Transrectal (TR); | ✓ | ✓ |
| ● Transvaginal (TV); | ✓ | ✓ |
| ● Intraoperative (abdominal, thoracic, & vascular). | ✓ | ✓ |

22

Image /page/22/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are enclosed within a circular shape, and the entire logo is presented in a blue color scheme.

GE Healthcare

510(k) Premarket Notification

| Transducer Arrays: | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------|
| Matrix Phased Array (incl single crystal) | ✓ | ✓ |
| Phased Array | ✓ | ✓ |
| Linear Array | ✓ | ✓ |
| Curved Array | ✓ | ✓ |
| Pencil (Doppler) | ✓ | ✓ |
| Ultrasound Modes: | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
| B, M, PW Doppler, CW Doppler, Color
Doppler, Color M Doppler, Power | ✓ | ✓ |
| Combined modes: B/M, B/Color M,
B/PWD or CWD, B/Color/PWD or CWD,
B/Power/PWD. | ✓ | ✓ |
| Harmonic | ✓ | ✓ |
| Coded Pulse | ✓ | ✓ |
| Real-time 3D & Multi-plane. | ✓ | ✓ |
| Processing & Display features: | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
| Image mapping (color & gray) | ✓ | ✓ |
| Time/ spatial filtering and enhancement, | ✓ | ✓ |
| TGC, TVI, SI/SRI, TSI, TSI w/ surface
rendering, Harmonic Imaging, | ✓ | ✓ |
| Pulsatile-Flow, B-Flow, Extended FOV,
Tissue Tracking, | ✓ | ✓ |
| Real-time 3D and Multi-plane processing, | ✓ | ✓ |
| Real-time 3D Color Flow, | ✓ | ✓ |
| Blood Flow Imaging (BFI), Spatial
Compounding / Speckle Reduction
imaging, Slice View, Laser-Lines,
Continuous Tissue Optimization (CTO) | ✓ | ✓ |
| Automated Functional Imaging (AFI) w/
Bull's Eye display, Triplane AFI. | ✓ | ✓ |
| LCD display, StereoVision,
2D Stress, Multiplane Stress | ✓ | ✓ |
| HDLive, Virtual Apex, 4D Auto AVQ | ✓ | ✓ |
| OLED display | Alternative to LCD | LCD display only |
| Processing & Display features:
(Continued) | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid S60/S70
(K142323) |
| AFI Stress, Smart Depth, Virtual Apex, 4D
Stress. | ✓ | ✓ |
| Standards Compliance: | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
| Designed and verified to meet harmonized
standards for Electrical Safety, EMC,
Biocompatibility. Software Life Cycle
Management, Risk Management and
Usability. | ✓ | ✓ |
| Track 3 (within FDA limits) | ✓ | ✓ |
| Transducers: | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid E9 (K131514) |
| ● M5Sc-D | ✓ | ✓ |
| ● 6S-D | ✓ | ✓ |
| ● 12S-D | ✓ | ✓ |
| ● 6VT-D | ✓ | ✓ |
| ● 6Tc | ✓ | ✓ |
| ● 6Tc -RS | ✓ | ✓ |
| ● 9T | ✓ | ✓ |
| ● 9T -RS | ✓ | ✓ |
| ● 9L-D | ✓ | ✓ |
| ● 11L-D | ✓ | ✓ |
| ● 8C | ✓ | ✓ |
| ● P2D | ✓ | ✓ |
| ● P6D | ✓ | ✓ |
| ● 4V-D | ✓ | ✓ |
| ● iC5-9-D | ✓ | ✓ |
| ● C2-9-D | ✓ | ✓ |
| Transducers: (Continued) | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Vivid S60/S70
(K142323) |
| ● C1-6-D | ✓ | ✓ |
| Transducers: (Continued) | Proposed Device
Vivid E80/E90/E95 | Predicate Device
Logiq E9 (K142160) |
| ● L8-18i-D | ✓ | ✓ |

23

GE Healthcare 510(k) Premarket Notification GE Vivid E80/E90/E95

Image /page/23/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. There are also three white swirls around the outside of the circle.

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output safety, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Vivid E80 / E90 / E95 and its applications comply with voluntary standards:

• 1. ANSI/AAMI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for basic safety and essential performance.
• 2. IEC60601-1-2, Medical Electrical Equipment -Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic Compatibility Requirements and Tests.
• 3. 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.
• 4. NEMA UD 3, Standard for Real Time Display of

24

Image /page/24/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 blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.

Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment.

• 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Fourth Edition.
• 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
• 7. ISO14971. Application of risk management to medical devices
• 8. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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

• Risk Analysis
• Requirement Reviews
• . Design Reviews
• Testing on unit level (Module verification) ●
• Integration testing (System verification) o
• . Performance testing (Verification)
• Safety testing (Verification) ●
• Final Acceptance Testing (Validation) ●

Summary of Clinical Tests:

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

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