510(k) K221281 ยท OWB Interventional Fluoroscopic X-Ray System
Multitom Rax
| Applicant | Siemens Medical Solutions, Malvern PA, US |
| Decision | Substantially Equivalent, Nov 17, 2022 |
| Received | May 3, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221281
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2024 | Siemens Medical Solutions USA, Inc Multitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image
Model Number: 10860700 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.