510(k) K193283 ยท QIH Automated Radiological Image Processing Software
AI-Rad Companion Prostate MR
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jul 30, 2020 |
| Received | Nov 27, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193283
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.