510(k) Report

Devices descending from K061941

14 later devices reach Leksell Gamma Knife Perfexion, Model 715000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102533Rotating Gamma System Infini (Infini)Masep Medical Science & Tech.Development (Shenzhen20111—
+1K063512Leksell Gamma Knife PerfexionElekta Instrument AB2007114
+2K131777Hyper Source-Unit Rotating Gamma SystemHyper Technology, Inc.20140—
+2K120811Leksell Gamma Knife PerfexionElekta Instrument AB201271
+2K092083Extend Frame System, Model 1009633Elekta Instrument AB200921
+3K133565Leksell Gamma Knife PerfexionElekta Instrument AB20146—
+3K112210FraxionMedical Intelligence Medizintechnik GmbH20111—
+4K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+4K151561Leksell Gamma Knife IconElekta Instrument AB201541
+4K132908Trupoint Arch, Nasion Cushion, Bite Cup, Trupoint Arch Storage Plate, Trupoint Arch Base…Medtec, Inc.20140—
+5K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+5K160440Leksell Gamma Knife IconElekta Instrument AB201631
+6K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+7K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501