Name: Predicase
Price: 199 USD

K-number	K222047
Device name	Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)
Applicant	Elekta Solutions AB
Product code	IWB
Device class	Class II
Decision date	Oct 26, 2022
Decision	Substantially Equivalent
Regulation	892.5750

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)

Everything you need for a 510(k) submission. Nothing you don't.