K250391

Substantially Equivalent

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)

Applicant: Elekta Solutions AB
Product code: IWB
Advisory panel: Radiology
Date received: 2025-02-12
Decision date: 2025-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.