510(k) K945619 ยท IZH System, X-Ray, Mammographic
ATHENA HFX
| Applicant | Fischer Imaging Corp., Denver CO, US |
| Decision | Substantially Equivalent, Mar 23, 1995 |
| Received | Nov 15, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945619
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.