K-number	K160440
Device name	Leksell Gamma Knife Icon
Applicant	Elekta Instrument AB
Product code	IWB
Device class	Class II
Decision date	Apr 20, 2016
Decision	Substantially Equivalent
Regulation	892.5750

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Source

View the full FDA submission: accessdata.fda.gov

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Leksell Gamma Knife Icon

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