510(k) Report

Devices descending from K040585

41 later devices reach Exactrac 4.0 and Exactrac X-Ray 6D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072506Exactrac 5.5Brainlab AG2007151
+1K072046Exactrac 3RD Party, Exactrac X-Ray 6D 3RD Party, Exactrac OemBrainlab AG200713—
+1K060906Calypso 4D Localization SystemCalypso Medical Technologies, Inc.200611—
+1K061713MAGIS1;MAGIS2Direx Systems Corp.20060—
+1K052212MIGUEDirex Systems Corp.20061—
+2K203722RayPilot SystemMicropos Medical AB20210—
+2K140823Permanent Beacon Transponder/Soft Tissue Beacon TransponderVarian Medical Systems, Inc.20142—
+2K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+2K132847I2CIon Beam Applications S.A.201303
+2K121663ClarityElekta, Ltd.20121—
+2K123137Calypso SystemVarian Medical Systems20123—
+2K122451Exactrac VeroBrainlab AG2012102
+2K120789Exactrac X-Ray X-RayBrainlab AG201286
+2K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+2K112768Calypso Systems with Dynamic Edge GatingCalypso Medical Technologies, Inc.20114—
+2K102373Calypso System with Dynamic Edge GatingCalypso Medical Technologies, Inc.20106—
+2K092550Tigrt IvsLinatech, LLC20090—
+2K080726Calypso 4D Localization SystemCalypso Medical Technologies, Inc.20089—
+2K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+3K201276ExacTrac DynamicBrainlab AG202061
+3K192405Image Guidance System for RadiotherapyJiangsu Rayer Medical Technology Co., Ltd.20200—
+3K181789VeriSuiteMedcom GmbH20180—
+3K170570Anchored Beacon (R) transponder, Anchored transponder, Beacon Care Package - LungVarian Medical Systems, Inc.20180—
+3K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+3K152761Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft…Varian Medical Systems, Inc.20150—
+3K141855ClarityElekta, Ltd.20140—
+3K131965XVI R5.0Elekta Limited20138—
+3K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+4K220338ExacTrac DynamicBrainlab AG202231
+4K211939ExacTrac DynamicBrainlab AG202101
+4K203173ExacTrac DynamicBrainlab AG202001
+4K161400ImagingRing SystemMedphoton GmbH20161—
+4K151561Leksell Gamma Knife IconElekta Instrument AB201541
+5K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG20241—
+5K231052ExacTrac Dynamic 1.1.2Brainlab AG20230—
+5K191267ImagingRing System on RailsMedphoton GmbH20190—
+5K160440Leksell Gamma Knife IconElekta Instrument AB201631
+6K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE20260—
+6K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+7K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+8K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501