510(k) K001171 ยท IZH System, X-Ray, Mammographic
DELTA 16 TACT
| Applicant | Instrumentarium Imaging, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, May 12, 2000 |
| Received | Apr 11, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001171
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.