VIVID I AND VIVID Q
FDA 510(k) clearance K082374 · decided 2008-09-02
Clearance details
- K-number
- K082374
- Device name
- VIVID I AND VIVID Q
- Applicant
- Ge Medical Systems Israel, Ultrasound, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-08-18
- Decision date
- 2008-09-02
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Tirat Carmel, IL
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems Israel
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374 recall (Z-0756-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal recall (Z-0757-2023) | GE Medical Systems, LLC | 2022-12-22 |