OEC 9900 ELITE
FDA 510(k) clearance K120613 · decided 2012-04-06
Clearance details
- K-number
- K120613
- Device name
- OEC 9900 ELITE
- Applicant
- Ge Healthcare Surgery GE Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-02-29
- Decision date
- 2012-04-06
- Days to decision
- 37 days
- Clearance type
- Special
- Product code
- OXO
- 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 |
| Field Upgrade Kits: P/N 5451208 RIU, 9 INCH, TOSHIBA; P/N 5485304 SERVICE PART, IMAGE INTE recall (Z-2279-2023) | GE OEC Medical Systems, Inc | 2023-07-31 |
| The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient recall (Z-2872-2020) | Ge Healthcare | 2020-08-27 |
| OEC 9900 Elite. MDL Numbers: D148942, D155043 recall (Z-1060-2017) | GE OEC Medical Systems, Inc | 2017-01-20 |
| The OEC 9900 Elite mobile fluoroscopy system is designed to provide fluoroscopic and spot- recall (Z-0975-2017) | GE OEC Medical Systems, Inc | 2017-01-09 |