510(k) K250660 ยท OWB Interventional Fluoroscopic X-Ray System
LUMINOS Q.namix T; LUMINOS Q.namix R
| Applicant | Siemens Medical Solutions, Malvern PA, US |
| Decision | Substantially Equivalent, Jul 14, 2025 |
| Received | Mar 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2026 | Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R;
Siemens Material Number (SMN): 11574002;
With Software Version VB10D-SP02 Open, Classified |
OWB | None listed |
| Jan 27, 2026 | Siemens Medical Solutions USA, Inc Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T;
Siemens Material Number (SMN): 11574003;
With Software Version VB10D-SP02 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.