510(k) K183272 ยท LLZ System, Image Processing, Radiological
AI Rad Companion (Engine)
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Feb 1, 2019 |
| Received | Nov 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183272
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.