K-number	K173789
Device name	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
Applicant	Elekta Instrument AB
Product code	IWB
Device class	Class II
Decision date	Mar 30, 2018
Decision	Substantially Equivalent
Regulation	892.5750

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View the full FDA submission: accessdata.fda.gov

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Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon

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