K160440

Substantially Equivalent

Leksell Gamma Knife Icon

Applicant: Elekta Instrument AB
Product 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.