510(k) K191879 ยท KPR System, X-Ray, Stationary
DRX-Evolution with Carestream Digital Tomosynthesis
| Applicant | Carestream Health, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 20, 2019 |
| Received | Jul 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191879
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.