510(k) K955411 ยท IZH System, X-Ray, Mammographic
DELTA 16
| Applicant | Instrumentarium Imaging, Inc., Tuusula, Finland, FI |
| Decision | Substantially Equivalent, Mar 21, 1996 |
| Received | Nov 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955411
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.