510(k) Report

Devices descending from K051932

17 later devices reach Elekta Synergy; Elekta Synergy S and XVIR3.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+1K100115XVI R4.5Elekta, Ltd.201094
+1K080585Desktop ProElekta, Ltd.200821
+2K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+2K131965XVI R5.0Elekta Limited20138—
+2K102200Integrity Model 1014284Elekta, Ltd.20101—
+3K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+3K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+3K161400ImagingRing SystemMedphoton GmbH20161—
+3K151561Leksell Gamma Knife IconElekta Instrument AB201541
+3K112613Integrity (TM)Elekta Limited201103
+4K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+4K191267ImagingRing System on RailsMedphoton GmbH20190—
+4K160440Leksell Gamma Knife IconElekta Instrument AB201631
+5K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+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