OEC One CFD is an AI-enabled medical device from Ge Hualun Medical Systems Co. , Ltd., listed by FDA (510(k), K253269) with a decision date of 2025-11-26. Review panel: Radiology.
| FDA submission number | K253269 |
|---|---|
| Pathway | 510(k) |
| Company | Ge Hualun Medical Systems Co. , Ltd. |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-11-26 |
| Decision | Substantially Equivalent |
| Product code | OXO |
| Classification | Image-Intensified Fluoroscopic X-Ray System, Mobile |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 58 |
| Applicant country | CN |
Official FDA database record · FDA AI-enabled device list
All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.