510(k) K984092 ยท IZH System, X-Ray, Mammographic
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
| Applicant | Trex Medical Corp., Copiague NY, US |
| Decision | Substantially Equivalent, Feb 5, 1999 |
| Received | Nov 16, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984092
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.