LUMINOS Q.namix T; LUMINOS Q.namix R is an AI-enabled medical device from Siemens Medical Solutions, listed by FDA (510(k), K250660) with a decision date of 2025-07-14. Review panel: Radiology.
| FDA submission number | K250660 |
|---|---|
| Pathway | 510(k) |
| Company | Siemens Medical Solutions |
| Review panel (specialty) | Radiology |
| FDA decision date | 2025-07-14 |
| Decision | Substantially Equivalent |
| Product code | OWB |
| Classification | Interventional Fluoroscopic X-Ray System |
| Device class | 2 |
| Regulation number | 892.1650 |
| Review time (calendar days) | 131 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
More devices from Siemens Medical Solutions · All Radiology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.