MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND— 510(k) K092079
Substantially EquivalentGe Medical Systems Israel, Ultrasound, Ltd.
FDA 510(k) clearance K092079 for MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND, Substantially Equivalent on 2009-08-06. Applicant: Ge Medical Systems Israel, Ultrasound, Ltd..
Clearance details
- Applicant
- Ge Medical Systems Israel, Ultrasound, Ltd.
- Product code
- Code IYN
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waukesha, WI, US
Adverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.