510(k) K222047 ยท IWB System, Radiation Therapy, Radionuclide
Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Oct 26, 2022 |
| Received | Jul 12, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222047
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.