3DXR is an AI-enabled medical device from GE Medical Systems SCS, listed by FDA (510(k), K243446) with a decision date of 2025-02-25. Review panel: Radiology.
| FDA submission number | K243446 |
|---|---|
| Pathway | 510(k) |
| Company | GE Medical Systems SCS |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-02-25 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 111 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
More devices from GE Medical Systems SCS · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.