510(k) K100692 ยท IZH System, X-Ray, Mammographic
DIGITAL SPOT MAMMOGRAPHY SYSTEM
| Applicant | Hologic, Inc., Danbury CT, US |
| Decision | Substantially Equivalent, Apr 6, 2010 |
| Received | Mar 10, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100692
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.