Leksell Gamma Knife Icon— 510(k) K160440

Substantially Equivalent

Elekta Instrument AB

FDA 510(k) clearance K160440 for Leksell Gamma Knife Icon, Substantially Equivalent on 2016-04-20. Applicant: Elekta Instrument AB.

Clearance details

Applicant: Elekta Instrument AB
Product code: Code IWB
Advisory panel: Radiology
Date received: 2016-02-17
Decision date: 2016-04-20
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.