OEC 3D
FDA 510(k) clearance K233669 · decided 2024-03-28
Clearance details
- K-number
- K233669
- Device name
- OEC 3D
- Applicant
- Ge Oec Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-15
- Decision date
- 2024-03-28
- Days to decision
- 134 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
+ Add to Predicate Builder ◉ Watch Ge Oec Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Digital C-ARM with 3D (K253296) | Allengers Medical Systems Limited | 2026-06-05 |
| Orthoscan TAU MVP Mini C-Arm System (K252579) | Ziehm-Orthoscan, Inc. | 2026-01-14 |
| OEC One CFD (K253269) | Ge Hualun Medical Systems Co. , Ltd. | 2025-11-26 |
| Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) (K251004) | Hefei Chimed Intelligent Machine Co., Ltd. | 2025-11-06 |
| Orthoscan TAU Mini C-Arm (K250587) | Ziehm-Orthoscan, Inc. | 2025-07-02 |
| Orthoscan VERSA Mini C-Arm (K243452) | Ziehm-Orthoscan, Inc. | 2025-01-14 |
| OEC One ASD (K240828) | Ge Hualun Medical Systems Co. , Ltd. | 2024-12-27 |
| Orthoscan Tau Mini C-Arm (K213113) | Orthoscan, Inc. | 2021-10-21 |
| OEC 3D (K203346) | Ge Oec Medical Systems, Inc. | 2021-03-05 |
| OEC Elite (K192819) | Ge Oec Medical Systems, Inc. | 2019-11-08 |
| Smart-C (K190024) | Turner Imaging Systems, Inc. | 2019-09-27 |
| OrthoScan TAU Mini C-Arm (K183220) | Orthoscan, Inc. | 2019-06-21 |
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 |