510(k) Report

Devices descending from K100115

9 later devices reach XVI R4.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131965XVI R5.0Elekta Limited20138—
+2K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+2K161400ImagingRing SystemMedphoton GmbH20161—
+2K151561Leksell Gamma Knife IconElekta Instrument AB201541
+3K191267ImagingRing System on RailsMedphoton GmbH20190—
+3K160440Leksell Gamma Knife IconElekta Instrument AB201631
+4K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+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