510(k) K912974 ยท IZH System, X-Ray, Mammographic
MAM-3RM-A MAMMOGRAPHIC X-RAY SYSTEM
| Applicant | Elscint, Inc., Hackensack NJ, US |
| Decision | Substantially Equivalent, Sep 19, 1991 |
| Received | Jul 8, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912974
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.