SERIES 6600 DIGITAL MOBILE C-ARM— 510(k) K951765
Substantially EquivalentGe Dec Medical Systems
FDA 510(k) clearance K951765 for SERIES 6600 DIGITAL MOBILE C-ARM, Substantially Equivalent on 1995-05-11. Applicant: Ge Dec Medical Systems. Device class: 2.
Clearance details
- Applicant
- Ge Dec Medical Systems
- Product code
- Code OXO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code OXO
view allMore clearances from Ge Dec Medical Systems
view allAdverse events under product code OXO
product code OXO- Death
- 6
- Injury
- 163
- Malfunction
- 2,099
- Other
- 1
- Total
- 2,269
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.