510(k) K191495 ยท IZH System, X-Ray, Mammographic
Biopsy Positioner
| Applicant | Fujifilm Corporation, Ashigarakami-Gun, JP |
| Decision | Substantially Equivalent, Jul 3, 2019 |
| Received | Jun 5, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191495
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.