510(k) K191309 ยท LLZ System, Image Processing, Radiological
syngo.via MI Workflows VB40A, Scenium
| Applicant | Siemens Medical Soultions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Jul 19, 2019 |
| Received | May 14, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191309
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.