510(k) Report

Devices descending from K063512

11 later devices reach Leksell Gamma Knife Perfexion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K120811Leksell Gamma Knife PerfexionElekta Instrument AB201271
+1K092083Extend Frame System, Model 1009633Elekta Instrument AB200921
+2K133565Leksell Gamma Knife PerfexionElekta Instrument AB20146—
+2K112210FraxionMedical Intelligence Medizintechnik GmbH20111—
+3K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+3K151561Leksell Gamma Knife IconElekta Instrument AB201541
+3K132908Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…Medtec, Inc.20140—
+4K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+4K160440Leksell Gamma Knife IconElekta Instrument AB201631
+5K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+6K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501