510(k) K863710 ยท IZH System, X-Ray, Mammographic
ALPHA S/D DIAGNOSTIC X-RAY MAMMOGRAPHY UNIT
| Applicant | Ausonics Pty , Ltd., Suffield CT, US |
| Decision | Substantially Equivalent, Oct 14, 1986 |
| Received | Sep 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863710
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.