510(k) K103512 ยท IZH System, X-Ray, Mammographic
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
| Applicant | Hologic, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Jan 7, 2011 |
| Received | Nov 30, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103512
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.