OEC 3D
FDA 510(k) clearance K203346 · decided 2021-03-05
Clearance details
- K-number
- K203346
- Device name
- OEC 3D
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-13
- Decision date
- 2021-03-05
- Days to decision
- 112 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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| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OEC 3D recall (Z-1820-2025) | GE Medical Systems, LLC | 2025-06-09 |
| OEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile flu recall (Z-0703-2025) | GE OEC Medical Systems, Inc | 2024-12-18 |