Vivid E80, Vivid E90, Vivid E95
Device Facts
| Record ID | K170823 |
|---|---|
| Device Name | Vivid E80, Vivid E90, Vivid E95 |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Jun 12, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for 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 ultrasound console with keyboard, touch panel, and display; supports electronic array transducers (linear, curved, sector/phased, matrix, CW). Inputs: ultrasound signals from transducers. Processing: real-time 2D/3D/4D imaging, Doppler analysis (PW, CW, Color, Power, M-mode). Outputs: visual ultrasound images/analysis on display; DICOM-compatible networking. Used in clinical settings by physicians/technicians for cardiac, vascular, and general radiology. Features include Myocardial Work (strain-based), 4D Auto RVQ/MVQ (automated quantification), Blood Speckle Imaging (flow trajectories), and Virtual Convex (linear transducer technique). Output aids clinical decision-making via visualization and automated measurements. Benefits: high-performance imaging for diagnostic assessment.
Clinical Evidence
No clinical studies required. Substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing per standards (e.g., IEC 60601-1, IEC 60601-2-37, ISO 10993-1).
Technological Characteristics
Mobile ultrasound console; electronic array transducers (linear, curved, sector/phased, matrix, CW). Connectivity: LAN/WLAN, DICOM. Software: 2D/3D/4D imaging, Doppler modes. Biocompatible patient-contact materials. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 3, ISO 10993-1, ISO 14971.
Indications for Use
Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transesophageal, transrectal, transvaginal, and intraoperative applications. Used by or under direction of qualified physicians.
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 (K150087)
- LOGIQ E9 (K163077)
- Vivid S60, Vivid S70 (K142323)
- TomTec Arena TTA2 (K150122)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
GE Medical Systems Ultrasound and Primary Care Diagnostics % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
June 12, 2017
Re: K170823
Trade/Device Name: Vivid E80, Vivid E90, Vivid E95 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: May 15, 2017 Received: May 16, 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 (reporting of medical device-
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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.
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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (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 A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K170823
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) |
|-------------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid E80, Vivid E90 and Vivid E95. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. 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: 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: P2D Transducer: P6D
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. The color of the logo is blue, and the background is white.
#### 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] | |
| 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 | N | N | N | N | N | N | N | N | N | N | [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 E90/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- [2] Small organ includes breast, testes, thyroid.
- Cardiac is Adult and Pediatric. [3]
- Other use includes Urology/Prostate [4]
- Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV). [5]
- [6] 3D/4D Imaging mode
- [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]
- [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
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized, cursive font, enclosed within a circular border. The color of the logo and the border is a light blue.
### 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 | N | N | N | N | N | N | N | N | N | N | [8] |
| Pediatric | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Small Organ | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | [8] |
| Musculo-skeletal Superficial | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [7,8] |
| Vascular Access (IV, PICC) | P1 | P1 | P1 | P1 | P1 | N | P1 | P1 | P1 | P1 | [8] |
P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- Small organ includes breast, testes, thyroid. [2]
- Cardiac is Adult and Pediatric. [3]
- [4] Other use includes Urology/Prostate
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
- [10] Abdominal includes Aorta-Iliac Artery
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{6}------------------------------------------------
### 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 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [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 E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] Other use includes Urology/Prostate
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [6] 3D/4D Imaging mode
- [7] Includes image guidance 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 [9]
[10] Abdominal includes Aorta-Iliac Artery
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
#### Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative flourishes at the top, bottom, left, and right, resembling stylized petals or leaves. The logo is simple, recognizable, and associated with the multinational conglomerate corporation.
### 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<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 | [6,9] |
| 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 E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- [2] Small organ includes breast, testes, thyroid.
- [3] Cardiac is Adult and Pediatric.
- [4] Other use includes Urology/Prostate
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [6] 3D/4D Imaging mode
- [7] Includes image guidance 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 [9]
[10] Abdominal includes Aorta-Iliac Artery
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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### 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 | P | [8] |
| Abdominal | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [4,8] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | P | P | P | P | P | | P | [8] |
| Transvaginal | P | P | P | P | P | P | P | P | | P | [8] |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | | P | [8] |
P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); 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]
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
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/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are four small, stylized teardrop shapes evenly spaced around the outside of the circle, adding a decorative element to the design.
### 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 | | | | | | | | | | | | |
| Abdominal | P | P | P | P | P | P | P | P | N | P | [1,8,10] | |
| Pediatric | P | P | P | P | P | P | P | P | N | P | [8] | |
| Small Organ (specify) | P | P | P | P | P | P | P | P | N | P | [8] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | N | P | [8] | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | N | P | [8] | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | [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 | N | P | [8] | |
| Vascular Access (IV, PICC) | | | | | | | | | | | | |
P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); 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]
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- [9] Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD
- [10] Abdominal includes Aorta-Iliac Artery
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are four small, stylized teardrop shapes evenly spaced around the outer edge of the circle, adding a decorative element to the design.
### 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 | P | [8] | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | [1,8,10] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [8] | |
| Small Organ (specify) | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [8] | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other | P | P | P | P | P | P | P | P | P | P | [4,8] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | P | P | P | P | P | P | P | [7,8] | |
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | P | P | [8] | |
P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); 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 ાંઠા
- [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
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The color of the logo is blue, and the background is white.
### 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 | P1 | b1 | P1 | | bl | P1 | P1 | P1 | P1 | P1 | [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 | N | N | N | | N | N | N | N | N | N | [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 E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- Small organ includes breast, testes, thyroid. [2]
- Cardiac is Adult and Pediatric. [3]
- [4] Other use includes Urology/Prostate
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
- [10] Abdominal includes Aorta-Iliac Artery
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a light blue hue.
### 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<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 | | | | | | | | | | | |
| 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 | N | N | N | | N | N | N | N | N | N | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | P | P | P | P | P | [5,8] |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy | P | P | P | | P | P | P | P | P | P | [7,8] |
| Vascular Access (IV, PICC) | P | P | P | | P | P | P | P | P | P | [8] |
P = previously cleared by FDA on Vivid E80/Vivid E95 (K150087); P1 = previously cleared by FDA on LOGIQ E9 (K163077); P2 = previously cleared by FDA on Vivid S70/Vivid S60 (K142323); N = New indication
Notes: [1] Abdominal includes renal, GYN/Pelvic
- Small organ includes breast, testes, thyroid. [2]
- Cardiac is Adult and Pediatric. [3]
- [4] Other use includes Urology/Prostate
- [5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
- [6] 3D/4D Imaging mode
- Includes image guidance for freehand needle placement [7]
- Combined modes are: B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD [8]
- Combined modes are: B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD [a]
- [10] Abdominal includes Aorta-Iliac Artery
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined 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 M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
|…
