510(k) K190296 ยท KXK Source, Brachytherapy, Radionuclide
GammaTile
| Applicant | Gt Medical Technologies, Tempe AZ, US |
| Decision | Substantially Equivalent, Mar 13, 2019 |
| Received | Feb 11, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190296
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.