510(k) Report

Devices descending from K133565

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

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