510(k) K190839 ยท KXK Source, Brachytherapy, Radionuclide
GammaTile
| Applicant | Gt Medical Technologies, Tempe AZ, US |
| Decision | Substantially Equivalent, Jan 23, 2020 |
| Received | Apr 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190839
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.