510(k) K850173 ยท IZH System, X-Ray, Mammographic
AUSONICS-ALPHA I DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
| Applicant | Ausonics Pty , Ltd., Suffield CT, US |
| Decision | Substantially Equivalent, Apr 16, 1985 |
| Received | Jan 16, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850173
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.