OEC 9900 ELITE
FDA 510(k) clearance K082781 · decided 2009-05-01
Clearance details
- K-number
- K082781
- Device name
- OEC 9900 ELITE
- Applicant
- Ge Healthcare Surgery
- Decision
- Substantially Equivalent
- Date received
- 2008-09-22
- Decision date
- 2009-05-01
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- OWB
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE HealthCare OEC 9900 Elite C-arm Systems. recall (Z-2342-2025) | GE Medical Systems, LLC | 2025-08-22 |
| OEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite mobil recall (Z-0705-2025) | GE OEC Medical Systems, Inc | 2024-12-18 |
| OEC 9900 Systems with 9-inch Image Intensifier recall (Z-2277-2023) | GE OEC Medical Systems, Inc | 2023-07-31 |
| The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is des recall (Z-1462-2014) | GE OEC Medical Systems, Inc | 2014-04-16 |