510(k) K173789 ยท IWB System, Radiation Therapy, Radionuclide
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
| Applicant | Elekta Instrument AB, Stockholm, SE |
| Decision | Substantially Equivalent, Mar 30, 2018 |
| Received | Dec 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173789
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.