510(k) K152038 ยท IZH System, X-Ray, Mammographic
MammoGRIP
| Applicant | Women'S Imaging Solutions Enterprises, LLC, Cresskill NJ, US |
| Decision | Substantially Equivalent, Dec 22, 2015 |
| Received | Jul 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152038
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.