Digital C-ARM with 3D
FDA 510(k) clearance K253296 · decided 2026-06-05
Clearance details
- K-number
- K253296
- Device name
- Digital C-ARM with 3D
- Applicant
- Allengers Medical Systems Limited
- Decision
- Substantially Equivalent
- Date received
- 2025-09-29
- Decision date
- 2026-06-05
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- OXO
- Device class
- 2
- Regulation number
- 892.1650
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Sas Nagar Mohali, IN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 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 |
| OEC 3D (K233669) | Ge Oec Medical Systems, Inc. | 2024-03-28 |
| 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
No recalls on record reference this clearance.