510(k) K173408 ยท MUE Full Field Digital, System, X-Ray, Mammographic
Mammomat Revelation
| Applicant | Siemens Medi Cal Solutions, Inc., Malvern PA, US |
| Decision | Substantially Equivalent, Mar 21, 2018 |
| Received | Nov 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173408
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 16, 2020 | Siemens Medical Solutions USA, Inc MAMMOMAT Revelation, model no. 11343300 - Product Usage: is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical prof Terminated |
MUE | None listed |
| Jul 23, 2019 | Siemens Medical Solutions USA, Inc Mammomat Revelation with software version VC10 and Biopsy Option
Intended Use: For mammography exams, screening, diagnostics, biopsies and dual energy procedures Terminated |
MUE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.