510(k) K905748 ยท IZH System, X-Ray, Mammographic
MAMEX DC AMI SL12/MG15
| Applicant | Soredex, Inc., Sf-00511 Helsinki Finland, FI |
| Decision | Substantially Equivalent, Mar 7, 1991 |
| Received | Dec 26, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905748
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.