510(k) K111434 ยท MUE Full Field Digital, System, X-Ray, Mammographic
GIOTTO IMAGE 3D, GIOTTO IMAGE 3D-L
| Applicant | Giotto USA, LLC, Indianpolis IN, US |
| Decision | Substantially Equivalent, Oct 27, 2011 |
| Received | May 23, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111434
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.