510(k) K153486 ยท IZH System, X-Ray, Mammographic
Affirm Prone Biopsy System
| Applicant | Hologic, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Apr 1, 2016 |
| Received | Dec 4, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153486
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.