510(k) K864958 ยท IZH System, X-Ray, Mammographic
ALPHA II DIAGNOSTIC X-RAY
| Applicant | Ausonics Pty , Ltd., Suffield CT, US |
| Decision | Substantially Equivalent, Jan 30, 1987 |
| Received | Dec 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864958
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.