510(k) K884345 ยท IZH System, X-Ray, Mammographic
MODEL ESP-200 MAMMOGRAPHIC SYSTEM
| Applicant | Acoma Medical Imaging, Inc., Wheeling IL, US |
| Decision | Substantially Equivalent, Mar 23, 1989 |
| Received | Oct 14, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884345
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.