510(k) K180515 ยท KXK Source, Brachytherapy, Radionuclide
GammaTile
| Applicant | Isoray Medical, Inc., Richland WA, US |
| Decision | Substantially Equivalent, Jul 6, 2018 |
| Received | Feb 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180515
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.