510(k) K990192 ยท IZH System, X-Ray, Mammographic
BIOPSY-DIGIT
| Applicant | Sitco, Inc., Arlington Heights IL, US |
| Decision | Substantially Equivalent, Mar 12, 1999 |
| Received | Jan 21, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990192
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.