510(k) K062039 ยท IZH System, X-Ray, Mammographic
BIOPSY DIGIT-AM
| Applicant | Giotto USA, LLC, Carmel IN, US |
| Decision | Substantially Equivalent, Sep 11, 2006 |
| Received | Jul 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062039
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.