510(k) K010792 ยท IZH System, X-Ray, Mammographic
MAMMOGRAPH
| Applicant | Digitec Medical Service Corp., Lawrenceville GA, US |
| Decision | Substantially Equivalent, Apr 3, 2001 |
| Received | Mar 16, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010792
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.