510(k) K162954 ยท NZT Dosimeter, Ionizing Radiation, Implanted
OARtrac System with Patient Specific Reusable Universal PSD Sensors
| Applicant | Radiadyne, LLC, Houston TX, US |
| Decision | Substantially Equivalent, Jun 1, 2017 |
| Received | Oct 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162954
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.