510(k) K964069 ยท IZH System, X-Ray, Mammographic
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
| Applicant | Siemens Medical Solutions USA, Inc., Iselin NJ, US |
| Decision | Substantially Equivalent, May 8, 1997 |
| Received | Oct 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964069
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.