Leksell Gamma Knife Icon— 510(k) K151561

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K151561 for Leksell Gamma Knife Icon, Substantially Equivalent on 2015-08-04. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Advisory panel: Radiology
Date received: 2015-06-10
Decision date: 2015-08-04
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.