510(k) K113607 ยท IZH System, X-Ray, Mammographic
BIOPSY DIGIT S BIOPSY SL
| Applicant | Giotto USA, LLC, Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Aug 10, 2012 |
| Received | Dec 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113607
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.