OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile Class II
FDA product code OXO covers "Image-Intensified Fluoroscopic X-Ray System, Mobile", a Class II medical device regulated under 21 CFR 892.1650. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OXO
- Device Class
- Class II
- Regulation Number
- 892.1650
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Definition
Fluoroscopy of the human body.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253296 | allengers medical systems limited | Digital C-ARM with 3D | June 5, 2026 |
| K252579 | ziehm-orthoscan | Orthoscan TAU MVP Mini C-Arm System | January 14, 2026 |
| K253269 | ge hualun medical systems co. | OEC One CFD | November 26, 2025 |
| K251004 | hefei chimed intelligent machine co | Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) | November 6, 2025 |
| K250587 | ziehm-orthoscan | Orthoscan TAU Mini C-Arm | July 2, 2025 |
| K243452 | ziehm-orthoscan | Orthoscan VERSA Mini C-Arm | January 14, 2025 |
| K240828 | ge hualun medical systems co. | OEC One ASD | December 27, 2024 |
| K233669 | ge oec medical systems | OEC 3D | March 28, 2024 |
| K213113 | orthoscan | Orthoscan Tau Mini C-Arm | October 21, 2021 |
| K203346 | ge oec medical systems | OEC 3D | March 5, 2021 |
| K192819 | ge oec medical systems | OEC Elite | November 8, 2019 |
| K190024 | turner imaging systems | Smart-C | September 27, 2019 |
| K183220 | orthoscan | OrthoScan TAU Mini C-Arm | June 21, 2019 |
| K182626 | ge hualun medical systems co. | OEC One | November 16, 2018 |
| K170946 | skanray technologies private limited | Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray Syste | November 24, 2017 |
| K172550 | ge oec medical systems | OEC Elite | November 16, 2017 |
| K171800 | ge hualun medical systems co. | OEC Elite MiniView | July 12, 2017 |
| K163429 | beijing east whale imaging technology co | B6 | January 4, 2017 |
| K160984 | beijing east whale imaging technology co | MultiScan G-Arm System | July 20, 2016 |
| K160131 | ge hangwei medical systems co | OEC Elite MiniView | June 21, 2016 |