510(k) Report

Devices descending from K983629

108 later devices reach RPM Respiratory Gating System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123808AgilityElekta, Ltd.2013362
+1K092845RespisensNomics20101—
+1K063270RPM Respiratory Gating SystemVarian Medical Systems, Inc.2006831
+1K061187TSX-201A, Aquilion LB CT Scanner with Respiratory GatingToshiba America Medical Systems, In.C20060—
+1K033287Exactrac GatingBrainlab AG200316—
+1K031385Anzai AZ-733 Respiratory Gating SystemAnzai Medical Co., Ltd.20035—
+1K020294Motion TrackingAccuray, Inc.200202
+2K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+2K160432Anzai Respiratory Gating SystemAnzai Medical Co., Ltd.20162—
+2K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+2K131313Active Breathing CoordinatorAktina Medical Corp.20131—
+2K112841Surface Beacon TranspondersCalypso Medical Technologies, Inc.20120—
+2K102024RPM Respiratory Gating SystemVarian Medical Systems201061
+2K092871Trilogy MXVarian Medical Systems, Inc.2009615
+2K072506Exactrac 5.5Brainlab AG2007151
+2K072171Gatect-RTVision RT Limited200712—
+3K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+3K170719Anzai Respiratory Gating SystemAnzai Medical Co., Ltd.20171—
+3K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+3K151533Respiratory Gating for ScannersVarian Medical Systems, Inc.20153—
+3K151097Active Breathing CoordinatorAktina Medical Corporation20150—
+3K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+3K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH20142—
+3K123371Alignrt PlusVision RT Limited201385
+3K121845SDX SystemDyn'R Sas20120—
+3K120789Exactrac X-Ray X-RayBrainlab AG201286
+3K111862Viewray SystemViewray, Incorporated201299
+3K113276CatalystC-Rad Positioning AB201221
+3K111106TruebeamVarian Medical Systems, Inc.2011435
+3K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+3K080742Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH20085—
+4K243900eMotus Respiratory Motion Management SystemEmpnia, Inc.20250—
+4K241937Klarity SGRT System (ARSG-E1A, ARSG-E3A)Klarity Medical & Equipment (GZ) Co., Ltd.20250—
+4K213927Respiratory Gating for Scanners v2.0Varian Medical Systems, Inc.20222—
+4K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+4K201276ExacTrac DynamicBrainlab AG202061
+4K200435Catalyst+, Catalyst+ HDC-Rad Positioning AB202002
+4K192405Image Guidance System for RadiotherapyJiangsu Rayer Medical Technology Co., Ltd.20200—
+4K183037Monaco RTP SystemElekta, Inc.201856
+4K181789VeriSuiteMedcom GmbH20180—
+4K181218AlignRT PlusVision Rt, Ltd.20187—
+4K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+4K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+4K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+4K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+4K160440Leksell Gamma Knife IconElekta Instrument AB201631
+4K150706VitalBeamVarian Medical Systems, Inc.201501
+4K132847I2CIon Beam Applications S.A.201303
+4K123291TruebeamVarian Medical Systems, Inc.201237—
+4K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH20093—
+5K253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.20260—
+5K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+5K242874Gating Reflector BlockVarian Medical Systems, Inc.20240—
+5K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+5K220338ExacTrac DynamicBrainlab AG202231
+5K211939ExacTrac DynamicBrainlab AG202101
+5K203173ExacTrac DynamicBrainlab AG202001
+5K193431AlignRT PlusVision Rt, Ltd.20206—
+5K190178Monaco RTP SystemElekta, Inc.201945
+5K181989MRIdian Linac SystemViewray, Incorporated201912
+5K172013VitalBeamVarian Medical Systems, Inc.20175—
+5K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+5K170817HalcyonVarian Medical Systems, Inc.201715—
+5K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+5K131965XVI R5.0Elekta Limited20138—
+6K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+6K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG20241—
+6K231052ExacTrac Dynamic 1.1.2Brainlab AG20230—
+6K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+6K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+6K212958MRIdian Linac SystemViewray, Incorporated20210—
+6K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+6K203387AlignRT PlusVision Rt, Ltd.20215—
+6K202789Monaco Rtp SystemElekta Solutions AB20213—
+6K182076Elekta UnityElekta Limited201834
+6K181032HalcyonVarian Medical Systems, Inc.201814—
+6K161400ImagingRing SystemMedphoton GmbH20161—
+6K151561Leksell Gamma Knife IconElekta Instrument AB201541
+7K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE20260—
+7K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+7K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+7K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+7K213787Monaco RTP SystemElekta Solutions AB20222—
+7K212583AlignRT PlusVision Rt, Ltd.20214—
+7K193207TaiChiAOur United Corporation20201—
+7K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+7K192482Elekta UnityElekta Limited201923
+7K191267ImagingRing System on RailsMedphoton GmbH20190—
+8K233622AlignRT PlusVision Rt, Ltd.20242—
+8K232031LUNA 3DLap GmbH Laser Applikationen20240—
+8K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+8K223233Monaco RTP SystemElekta Solutions AB20231—
+8K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+8K210921TaiChiBOur United Corporation20210—
+8K212114Elekta UnityElekta Solutions AB202111
+8K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+9K253004LUNA 3DLap GmbH Laser Applikationen20260—
+9K253012AlignRT Plus (8.0)Vision Rt, Ltd.20260—
+9K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+9K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—