VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
FDA 510(k) clearance K102388 · decided 2010-11-04
Clearance details
- K-number
- K102388
- Device name
- VIVID I DIAGNOSTIC ULTRASOUND SYSTEM
- Applicant
- Ge Medical System Israel , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-23
- Decision date
- 2010-11-04
- Days to decision
- 73 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Wauwatosa, WI, US
- Third-party review
- No
- Expedited review
- No
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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 |