510(k) K122836 ยท IZH System, X-Ray, Mammographic
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
| Applicant | Lorad, A Hologic Co., Danbury CT, US |
| Decision | Substantially Equivalent, Jan 11, 2013 |
| Received | Sep 17, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122836
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.