Vivid E80, Vivid E90, Vivid E95
Device Facts
| Record ID | K173341 |
|---|---|
| Device Name | Vivid E80, Vivid E90, Vivid E95 |
| Applicant | GE Medical Systems |
| Product Code | IYN · Radiology |
| Decision Date | Nov 2, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Device Story
Mobile diagnostic ultrasound system for cardiac, vascular, and general radiology. Inputs: electronic array transducers (linear, curved, sector/phased, matrix). Processing: high-performance GPU-based signal processing for 2D and real-time 3D/4D imaging. Outputs: ultrasound images/analysis displayed on integrated OLED/LCD panels. Used in clinical settings (e.g., cardiology, radiology) by physicians or trained sonographers. Provides high-speed 4D volume rates via upgraded GPU. Supports DICOM networking for image storage/printing. Benefits: enables real-time visualization and analysis of anatomical structures and fluid flow to assist in clinical diagnosis and interventional guidance.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety, as well as system verification and validation (risk analysis, usability, design reviews).
Technological Characteristics
Mobile console with keyboard/touch panel and OLED/LCD display. Employs electronic array transducers (linear, curved, sector/phased, matrix). Connectivity: DICOM, DVI. Safety standards: ANSI/AAMI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, IEC62359, ISO14971.
Indications for Use
Indicated for ultrasound imaging and analysis of fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, transvaginal, and intraoperative applications. Intended for use by or under the direction of a qualified physician.
Regulatory Classification
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.
Predicate Devices
- Vivid E80, Vivid E90, Vivid E95 (K170823)
Related Devices
- K211216 — Vivid S60N / Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 9, 2021
- K202658 — Vivid E80/ Vivid E90/ Vivid E95 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Mar 5, 2021
- K170823 — Vivid E80, Vivid E90, Vivid E95 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 12, 2017
- K220619 — Vivid S60N, Vivid S70N · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jul 15, 2022
- K200851 — Vivid T8, Vivid T9 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 9, 2020
Submission Summary (Full Text)
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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
November 2, 2017
# Re: K173341
Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: October 24, 2017 Received: October 25, 2017
Dear Ms. Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael D. O'Hara For
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
### K173341
Device Name Vivid E80 Vivid E90 Vivid E95
Indications for Use (Describe)
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).
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
# CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid E80, Vivid E90 and Vivid E95. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
System: Vivid E80 / Vivid E90 / Vivid E95 Transducer: C3-10-D Transducer: 12S-D Transducer: 4V-D Transducer: 4Vc-D Transducer: iC5-9-D Transducer: 8C Transducer: C2-9-D Transducer: 9L-D Transducer: 11L-D Transducer: M5Sc-D Transducer: 6S-D Transducer: C1-6-D Transducer: L8-18i-D Transducer: 6VT-D Transducer: 6Tc Transducer: 6Tc-RS Transducer: 9T Transducer: 9T-RS Transducer: 10T-D Transducer: P2D Transducer: P6D
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Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.
### Diagnostic Ultrasound Indications for Use Form Vivid E80 / Vivid E90 / Vivid E95 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [6,8,9,11] | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,6,8,9,10] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6,8,9] | |
| Small Organ | P | P | P | P | P | P | P | P | P | P | [2,8] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [8,9] | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6,9] | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [3,6,9] | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [8] | |
| Other | P | P | P | P | P | P | P | P | P | P | [4,6,8,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | [6,9] | |
| Transrectal | P | P | P | P | P | P | P | P | | P | [8] | |
| Transvaginal | P | P | P | P | P | P | P | P | | P | [8] | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative | P | P | P | P | P | P | P | P | P | P | [5,8] | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8,9] | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication
Notes: Abdominal includes renal, GYN/Pelvic [1]
- Small organ includes breast, testes, thyroid [2]
- Cardiac is Adult and Pediatric [3]
- Other use includes Urology/Prostate [4]
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
- 3D/4D Imaging mode [6]
- Includes image guidance for freehand needle placement [7]
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- ləl Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
- [11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/5/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around it. The logo is presented in a blue color scheme.
## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C3-10-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [8] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [8] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV. PICC) | P | P | P | P | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
- [7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/6/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a double border, with the inner border being a slightly lighter shade of blue. There are decorative white swirls around the letters, adding a touch of elegance to the design.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 12S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [9] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [3,9] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication
Notes: Abdominal includes renal, GYN/Pelvic [1]
- [2] Small organ includes breast, testes, thyroid
- [3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
- 3D/4D Imaging mode [6]
- [7] Includes image guidance for freehand needle placement
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
- [11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is rendered in a light blue color. The logo is simple, recognizable, and represents the General Electric brand.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4V-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | [6,9,11] |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,6,9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [6,9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [6,9] |
| Cardiac | P | P | P | P | P | P | P | P | P | P | [3,6,9] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [4,6,9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | | | | | | | | | | | |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication
Abdominal includes renal, GYN/Pelvic Notes: [1]
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
[4] Other use includes Urology/Prostate
Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
[7] Includes image guidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
ાં છો Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{8}------------------------------------------------
Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around the perimeter. The logo is presented in a blue color.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 4Vc-D Transducer
#### Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | [6,9,11] |
| Abdominal | N | N | N | N | N | N | N | N | N | N | [1,6,9] |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [6,9] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | [6,9] |
| Cardiac | N | N | N | N | N | N | N | N | N | N | [3,6,9] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | N | N | N | N | N | N | N | N | N | N | [4,6,9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | N | N | N | N | N | N | N | N | N | N | [9] |
| Vascular Access (IV. PICC) | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
[7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
[9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{9}------------------------------------------------
Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a decorative border with swirling patterns, giving it a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with iC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | [8,11] |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | | P | P | P | P | P | P | [4,8] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P | | P | [8] |
| Transvaginal | P | P | P | | P | P | P | P | | P | [8] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | | P | [8] |
P = previously cleared by FDA on Vivid E80/Vivid E90/Vivid E95 (K170823); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
3D/4D Imaging mode [6]
- [7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font inside. The letters are also blue and have a swirling design. The logo is simple and recognizable, and it is often used to represent the company.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 8C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | [1,8,10] | |
| Abdominal | P | P | P | | P | P | P | P | P | P | [1,8,10] | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [8] | |
| Small Organ (specify) | P | P | P | | P | P | P | P | P | P | [8] | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [8] | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [8] | |
| Vascular Access (IV. PICC) | | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
- [7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
Image /page/11/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the long-standing brand identity of General Electric.
### Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with C2-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | P | P | P | P | P | [8,11] | |
| Abdominal | P | P | P | | P | P | P | P | P | P | [1,8,10] | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [8] | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | P | P | P | | P | P | P | P | P | P | [4,8] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] | |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] | |
P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
- [7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border that has decorative, swirling elements around it. The logo is presented in a blue color scheme.
## Diagnostic Ultrasound Indications for Use Form GE Vivid E80 / Vivid E90 / Vivid E95 with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | P | P | P | | P | P | P | P | P | P | [8] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [8] |
| Small Organ | P | P | P | | P | P | P | P | P | P | [2,8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV. PICC) | P | P | P | | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid E90/Vivid E90/Vivid E95 (K170823); N = New indication
[1] Abdominal includes renal, GYN/Pelvic Notes:
[2] Small organ includes breast, testes, thyroid
[3] Cardiac is Adult and Pediatric
- [4] Other use includes Urology/Prostate
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV) [5]
3D/4D Imaging mode [6]
- [7] Includes image quidance for freehand needle placement
Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD ləl
[10] Abdominal includes Aorta-Iliac Artery
[11] Fetal/Obstetrics includes Fetal Heart
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)…
