510(k) K201670 ยท KPR System, X-Ray, Stationary
YSIO X.pree
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Oct 21, 2020 |
| Received | Jun 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201670
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2022 | Siemens Medical Solutions USA, Inc YSIO X.Pree Open, Classified |
KPR | None listed |
| Mar 10, 2021 | Siemens Medical Solutions USA, Inc Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull, chest, abdomen, and extremities. Terminated |
KPR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.