510(k) K210055 ยท OWB Interventional Fluoroscopic X-Ray System
Cios Alpha
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 5, 2021 |
| Received | Jan 8, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210055
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2023 | Siemens Medical Solutions USA, Inc Siemens Cios Alpha (VA30) mobile fluoroscopic C-arm X-ray System, designed for the surgical environment.
11105200 Open, Classified |
OWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.