510(k) K954521 ยท IZH System, X-Ray, Mammographic
MAMMOSPOT PADDLE
| Applicant | American Mammographics, Inc., Chattanooga TN, US |
| Decision | Substantially Equivalent, Oct 24, 1995 |
| Received | Sep 28, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954521
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.