510(k) K012953 ยท IZH System, X-Ray, Mammographic
GIOTTO IMAGE
| Applicant | Medx, Inc., Arlington Heights IL, US |
| Decision | Substantially Equivalent, Nov 30, 2001 |
| Received | Sep 4, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012953
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.