510(k) Report

Devices descending from K120811

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133565Leksell Gamma Knife PerfexionElekta Instrument AB20146—
+2K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+2K151561Leksell Gamma Knife IconElekta Instrument AB201541
+3K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+3K160440Leksell Gamma Knife IconElekta Instrument AB201631
+4K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+5K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501