510(k) Report

Devices descending from K040192

79 later devices reach ON-Board Imager Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132847I2CIon Beam Applications S.A.201303
+1K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC20100—
+1K042720ON-Board Imager DeviceVarian Medical Systems2004765
+1K041519Modification to: on-Board Imager DeviceVarian Medical Systems, Inc.200402
+2K133191Probeam Proton Therapy SystemVarian Medical Systems201431
+2K120789Exactrac X-Ray X-RayBrainlab AG201286
+2K092871Trilogy MXVarian Medical Systems, Inc.2009615
+3K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.20222—
+3K201276ExacTrac DynamicBrainlab AG202061
+3K192405Image Guidance System for RadiotherapyJiangsu Rayer Medical Technology Co., Ltd.20200—
+3K111862Viewray SystemViewray, Incorporated201299
+3K111106TruebeamVarian Medical Systems, Inc.2011435
+3K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+4K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.20260—
+4K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.20231—
+4K220338ExacTrac DynamicBrainlab AG202231
+4K211939ExacTrac DynamicBrainlab AG202101
+4K203173ExacTrac DynamicBrainlab AG202001
+4K183037Monaco RTP SystemElekta, Inc.201856
+4K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+4K123808AgilityElekta, Ltd.2013362
+4K123291TruebeamVarian Medical Systems, Inc.201237—
+5K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG20241—
+5K231052ExacTrac Dynamic 1.1.2Brainlab AG20230—
+5K190178Monaco RTP SystemElekta, Inc.201945
+5K181989MRIdian Linac SystemViewray, Incorporated201912
+5K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+5K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+5K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+5K131965XVI R5.0Elekta Limited20138—
+6K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE20260—
+6K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+6K212958MRIdian Linac SystemViewray, Incorporated20210—
+6K202789Monaco Rtp SystemElekta Solutions AB20213—
+6K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+6K182076Elekta UnityElekta Limited201834
+6K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+6K161400ImagingRing SystemMedphoton GmbH20161—
+6K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+6K151561Leksell Gamma Knife IconElekta Instrument AB201541
+6K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+7K213787Monaco RTP SystemElekta Solutions AB20222—
+7K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+7K192482Elekta UnityElekta Limited201923
+7K191267ImagingRing System on RailsMedphoton GmbH20190—
+7K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+7K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+7K160440Leksell Gamma Knife IconElekta Instrument AB201631
+7K150706VitalBeamVarian Medical Systems, Inc.201501
+8K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+8K223233Monaco RTP SystemElekta Solutions AB20231—
+8K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+8K212114Elekta UnityElekta Solutions AB202111
+8K172013VitalBeamVarian Medical Systems, Inc.20175—
+8K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+8K170817HalcyonVarian Medical Systems, Inc.201715—
+9K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+9K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+9K223209Elekta UnityElekta Solutions AB20230—
+9K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+9K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+9K181032HalcyonVarian Medical Systems, Inc.201814—
+10K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+10K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+10K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+10K193207TaiChiAOur United Corporation20201—
+10K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+11K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+11K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+11K210921TaiChiBOur United Corporation20210—
+11K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+12K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—
+12K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+12K232479ART-PlanTherapanacea20232—
+12K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+13K253078ART.1-USSeetreat Pty, Ltd.20260—
+13K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+13K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+14K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20260—