K250391
- 510(k) number
- K250391
- Device name
- Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)
- Applicant
- Elekta Solutions AB SE
- Product code
- IWB — System, Radiation Therapy, Radionuclide
- Decision date
- 2025-07-02
- Date received
- 2025-02-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250391.pdf
Official FDA record: K250391
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.