510(k) K964576 ยท IZH System, X-Ray, Mammographic
PROFILE MAMMOGRAPHY SYSTEM (M-PRO)
| Applicant | Bennett X-Ray Corp., Copiague NY, US |
| Decision | Substantially Equivalent, Jan 10, 1997 |
| Received | Nov 14, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964576
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.