510(k) K153119 ยท KPR System, X-Ray, Stationary
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System,
| Applicant | Summit Industries, LLC, Chicago IL, US |
| Decision | Substantially Equivalent, Mar 14, 2016 |
| Received | Oct 29, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153119
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.