Definium Tempo Select is an AI-enabled medical device from GE Hualun Medical Systems Co., Ltd, listed by FDA (510(k), K250788) with a decision date of 2025-08-28. Review panel: Radiology.
| FDA submission number | K250788 |
|---|---|
| Pathway | 510(k) |
| Company | GE Hualun Medical Systems Co., Ltd |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-08-28 |
| Decision | Substantially Equivalent |
| Product code | KPR |
| Classification | System, X-Ray, Stationary |
| Device class | 2 |
| Regulation number | 892.1680 |
| Review time (calendar days) | 167 |
| 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.