OXO — Image-Intensified Fluoroscopic X-Ray System, Mobile Class II
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 |
|---|---|---|---|
| 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 |
| K160065 | gemss medical systems co | GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System | May 20, 2016 |