510(k) Report

Devices descending from K943224

87 later devices reach Varian Multileaf Collimator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040804.Decimal Tissue Compensator/Intensity ModulatorSoutheastern Radiation Products, Inc.200415—
+1K973889Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc.199770—
+2K071078.Decimal Range Compensator.Decimal, Inc.20079—
+2K071077.Decimal Aperture.Decimal, Inc.20074—
+2K062781MOD1 Compensators for Radiation Beam TherapySymtium Corporation20061—
+2K052383Innocure Imrt Filter (Compensators)Innocure, LLC20060—
+2K990085Millennium MLC -120Varian Assoc., Inc.1999692
+3K131150Cura CompensatorCura Medical Technologies, LLC20130—
+3K123893Cura CollimatorCura Medical Technologies, LLC20130—
+3K121657Proton Radiation Therapy Beam-Shaping Aperture Proton Radiaion Therapy Beam-Shping Range…Proton Systems20122—
+3K091403MOD1T Compensators for Radiation Beam TherapyOncology Tech, LLC20090—
+3K091911Bolus Compensator.Decimal, Inc.20095—
+3K050442Millennium Multi-Leaf CollimatorVarian Medical Systems2005672
+3K042794Beam Modulator, Model 4513 332 8000Elekta, Ltd.20050—
+4K214093VSP Bolus3D Systems20222—
+4K211511decimal Bolus.Decimal, LLC20211—
+4K132236.Decimal Proton Aperture.Decimal, Inc.20130—
+4K093250Proton Therapy Multileaf CollimatorVarian Medical Systems20091—
+4K092871Trilogy MXVarian Medical Systems, Inc.2009615
+4K071992High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems2007644
+5K252784eXaSkin PlusAnatomical Geometry S.L.20260—
+5K222639VHA Radiotherapy BolusVha Dean20221—
+5K152207Extended Range Shifter for PROBEAT-VHitachi, Ltd., Health Care Company20150—
+5K133240Varian Multileaf CollimatorVarian Medical Systems, Inc.20141—
+5K111862Viewray SystemViewray, Incorporated201299
+5K111106TruebeamVarian Medical Systems, Inc.2011435
+5K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+6K253025Ricoh 3D for Healthcare BolusRicoh 3D For Healthcare, LLC20260—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorVarian Medical Systems, Inc.201801
+6K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+6K123808AgilityElekta, Ltd.2013362
+6K123291TruebeamVarian Medical Systems, Inc.201237—
+7K190178Monaco RTP SystemElekta, Inc.201945
+7K181989MRIdian Linac SystemViewray, Incorporated201912
+7K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+7K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+7K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+7K131965XVI R5.0Elekta Limited20138—
+8K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+8K212958MRIdian Linac SystemViewray, Incorporated20210—
+8K202789Monaco Rtp SystemElekta Solutions AB20213—
+8K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+8K182076Elekta UnityElekta Limited201834
+8K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+8K161400ImagingRing SystemMedphoton GmbH20161—
+8K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+8K151561Leksell Gamma Knife IconElekta Instrument AB201541
+8K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+9K213787Monaco RTP SystemElekta Solutions AB20222—
+9K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+9K192482Elekta UnityElekta Limited201923
+9K191267ImagingRing System on RailsMedphoton GmbH20190—
+9K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+9K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+9K160440Leksell Gamma Knife IconElekta Instrument AB201631
+9K150706VitalBeamVarian Medical Systems, Inc.201501
+10K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+10K223233Monaco RTP SystemElekta Solutions AB20231—
+10K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+10K212114Elekta UnityElekta Solutions AB202111
+10K172013VitalBeamVarian Medical Systems, Inc.20175—
+10K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+10K170817HalcyonVarian Medical Systems, Inc.201715—
+11K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+11K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+11K223209Elekta UnityElekta Solutions AB20230—
+11K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+11K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+11K181032HalcyonVarian Medical Systems, Inc.201814—
+12K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+12K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+12K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+12K193207TaiChiAOur United Corporation20201—
+12K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+13K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+13K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+13K210921TaiChiBOur United Corporation20210—
+13K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+14K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—
+14K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+14K232479ART-PlanTherapanacea20232—
+14K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+15K253078ART.1-USSeetreat Pty, Ltd.20260—
+15K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+15K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+16K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—