9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS— 510(k) K061953
Substantially EquivalentGe Oec Medical Systems
FDA 510(k) clearance K061953 for 9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS, Substantially Equivalent on 2006-08-15. Applicant: Ge Oec Medical Systems.
Clearance details
- Applicant
- Ge Oec Medical Systems
- Product code
- Code OWB
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
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.