510(k) K193166 ยท MUE Full Field Digital, System, X-Ray, Mammographic
MAMMOMAT Revelation
| Applicant | Siemens Medical Solutions USA, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Jun 12, 2020 |
| Received | Nov 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193166
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 3, 2025 | Siemens Medical Solutions USA, Inc MAMMOMAT Revelation; Open, Classified |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.