Ge Hualun Medical Systems Co. , Ltd.
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories3
Latest FDA decision2025-11-26
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253269 | OEC One CFD | OXO | 2025-11-26 | View |
| 510(k) | K250788 | Definium Tempo Select | KPR | 2025-08-28 | View |
| 510(k) | K240828 | OEC One ASD | OXO | 2024-12-27 | View |
| 510(k) | K242678 | Definium Pace Select ET | KPR | 2024-10-01 | View |
| 510(k) | K231892 | Definium Pace Select | KPR | 2023-09-12 | View |
| 510(k) | K191699 | Discovery XR656 HD with VolumeRad | KPR | 2019-07-24 | View |
| 510(k) | K182626 | OEC One | OXO | 2018-11-16 | View |
| 510(k) | K173612 | Optima XR646 HD | KPR | 2017-12-11 | View |
| 510(k) | K172700 | OEC One | OWB | 2017-11-09 | View |
| 510(k) | K172869 | Discovery XR656 HD | KPR | 2017-10-20 | View |
| 510(k) | K171800 | OEC Elite MiniView | OXO | 2017-07-12 | View |
No matching devices.