510(k) K250391 · IWB System, Radiation Therapy, Radionuclide
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
| Applicant | Elekta Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Jul 2, 2025 |
| Received | Feb 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250391
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2026 | Elekta, Inc. Brand Name: Leksell Gamma Knife
Product Description: Leksell Gamma Knife Perfexion
Leksell Gamma Knife Icon"
Leksell Gamma Knife Elekta Esprit
Leksell Gamma Knife (available models Elekta Esprit, Open, Classified |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.