510(k) K202294 ยท IZH System, X-Ray, Mammographic
Affirm Contrast Biopsy
| Applicant | Hologic, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Oct 5, 2020 |
| Received | Aug 13, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202294
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.