Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion)— 510(k) K250391

Substantially Equivalent

Elekta Solutions AB

FDA 510(k) clearance K250391 for Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion), Substantially Equivalent on 2025-07-02. Applicant: Elekta Solutions AB.

Clearance details

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

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