OEC Elite
FDA 510(k) clearance K172550 · decided 2017-11-16
Clearance details
- K-number
- K172550
- Device name
- OEC Elite
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-08-23
- Decision date
- 2017-11-16
- Days to decision
- 85 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot recall (Z-1819-2025) | GE Medical Systems, LLC | 2025-06-09 |
| OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C- recall (Z-0704-2025) | GE OEC Medical Systems, Inc | 2024-12-18 |
| OEC Elite Systems with 9-inch Image Intensifier recall (Z-2278-2023) | GE OEC Medical Systems, Inc | 2023-07-31 |