OXO
- Product code
- OXO
- Device name
- Image-Intensified Fluoroscopic X-Ray System, Mobile
- Device class
- Class 2
- 21 CFR
- 21 CFR 892.1650
- Medical specialty
- Radiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 8
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 82 (all years; only the last 3 years are listed here)
FDA classification definition
Fluoroscopy of the human body.
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253296 | 2026-06-05 | Allengers Medical Systems Limited | Digital C-ARM with 3D | |
| K252579 | 2026-01-14 | Ziehm-Orthoscan, Inc. | Orthoscan TAU MVP Mini C-Arm System | |
| K253269 | 2025-11-26 | Ge Hualun Medical Systems Co. , Ltd. | OEC One CFD | |
| K251004 | 2025-11-06 | Hefei Chimed Intelligent Machine Co., | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | |
| K250587 | 2025-07-02 | Ziehm-Orthoscan, Inc. | Orthoscan TAU Mini C-Arm | |
| K243452 | 2025-01-14 | Ziehm-Orthoscan, Inc. | Orthoscan VERSA Mini C-Arm | |
| K240828 | 2024-12-27 | Ge Hualun Medical Systems Co. , Ltd. | OEC One ASD | |
| K233669 | 2024-03-28 | Ge Oec Medical Systems, Inc. | OEC 3D |
Official FDA classification page: OXO
Classification and pathway per current FDA publications. Data from openFDA (CC0).