VIVID I AND VIVID Q— 510(k) K082374
Substantially EquivalentGe Medical Systems Israel, Ultrasound, Ltd.
FDA 510(k) clearance K082374 for VIVID I AND VIVID Q, Substantially Equivalent on 2008-09-02. 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
- Traditional
- Location
- Tirat Carmel, IL
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.