510(k) K042095 ยท IZH System, X-Ray, Mammographic
MAMMOTEST
| Applicant | Fischer Imaging Corp., Denver CO, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Aug 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042095
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2009 | Siemens Medical Solutions USA, Inc Mammo Test Model number 10144185, x-ray guided stereotactic biopsy system Terminated |
JAQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.