510(k) K193360 ยท KPR System, X-Ray, Stationary
Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard
| Applicant | Radmedix, LLC, Dayton OH, US |
| Decision | Substantially Equivalent, Jan 2, 2020 |
| Received | Dec 4, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193360
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.