GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND— 510(k) K092140
Substantially EquivalentGe Medical Systems Israel, Ultrasound, Ltd.
FDA 510(k) clearance K092140 for GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND, Substantially Equivalent on 2009-08-21. Applicant: Ge Medical Systems Israel, Ultrasound, Ltd..
Clearance details
- Applicant
- Ge Medical Systems Israel, Ultrasound, Ltd.
- Product code
- Code IYO
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Waukesha, WI, US
Adverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
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.