Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
FDA 510(k) clearance K150087 · decided 2015-03-04
Clearance details
- K-number
- K150087
- Device name
- Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System
- Applicant
- Ge Vingmed Ultrasound AS
- Decision
- Substantially Equivalent
- Date received
- 2015-01-15
- Decision date
- 2015-03-04
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Horten, NO
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581D recall (Z-2316-2024) | GE Vingmed Ultrasound As | 2024-07-05 |