MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
FDA 510(k) clearance K092079 · decided 2009-08-06
Clearance details
- K-number
- K092079
- Device name
- MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND
- Applicant
- Ge Medical Systems Israel, Ultrasound, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-09
- Decision date
- 2009-08-06
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- IYN
- Device class
- 2
- Regulation number
- 892.1550
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina recall (Z-0752-2023) | GE Medical Systems, LLC | 2022-12-22 |
| Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina recall (Z-0753-2023) | GE Medical Systems, LLC | 2022-12-22 |