510(k) Report

Devices descending from K003636

101 later devices reach Portalvision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC20100—
+1K092871Trilogy MXVarian Medical Systems, Inc.2009615
+1K091209Portalvision Advanced ImagingVarian Medical Systems, Inc.200921
+1K042733Standard Imaging Pipspro QA Software SystemStandard Imaging, Inc.20040—
+1K040192ON-Board Imager DeviceVarian Medical Systems, Inc.2004792
+1K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc.20031617
+2K200940BeamSiteDoseoptics, LLC20201—
+2K132847I2CIon Beam Applications S.A.201303
+2K111862Viewray SystemViewray, Incorporated201299
+2K111106TruebeamVarian Medical Systems, Inc.2011435
+2K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+2K060633Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Siemens Medical Solutions USA, Inc.200651
+2K060226Oncor ExpressionSiemens Medical Solutions USA, Inc.20061372
+2K052315Simtec IM-Maxx 2 OptionSiemens Medical Solutions USA, Inc.20054—
+2K042720ON-Board Imager DeviceVarian Medical Systems2004765
+2K041519Modification to: on-Board Imager DeviceVarian Medical Systems, Inc.200402
+3K212606BeamSiteDoseoptics, LLC20210—
+3K183037Monaco RTP SystemElekta, Inc.201856
+3K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+3K133191Probeam Proton Therapy SystemVarian Medical Systems201431
+3K123808AgilityElekta, Ltd.2013362
+3K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+3K123291TruebeamVarian Medical Systems, Inc.201237—
+3K120789Exactrac X-Ray X-RayBrainlab AG201286
+3K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+3K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+3K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+3K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+3K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+3K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+3K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+3K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+4K221791ProBeam 360° Proton Therapy SystemVarian Medical Systems, Inc.20222—
+4K201276ExacTrac DynamicBrainlab AG202061
+4K192405Image Guidance System for RadiotherapyJiangsu Rayer Medical Technology Co., Ltd.20200—
+4K190178Monaco RTP SystemElekta, Inc.201945
+4K181989MRIdian Linac SystemViewray, Incorporated201912
+4K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+4K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+4K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+4K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+4K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+4K131965XVI R5.0Elekta Limited20138—
+4K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+5K252815ProBeam 360 Proton Therapy System v3.0Varian Medical Systems, Inc.20260—
+5K231863ProBeam 360° Proton Therapy System v2.0 (Multiroom)Varian Medical Systems, Inc.20231—
+5K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+5K220338ExacTrac DynamicBrainlab AG202231
+5K212958MRIdian Linac SystemViewray, Incorporated20210—
+5K211939ExacTrac DynamicBrainlab AG202101
+5K202789Monaco Rtp SystemElekta Solutions AB20213—
+5K203173ExacTrac DynamicBrainlab AG202001
+5K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited20192—
+5K182076Elekta UnityElekta Limited201834
+5K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+5K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare20170—
+5K161400ImagingRing SystemMedphoton GmbH20161—
+5K151159Leksell Gamma Knife PerfexionElekta Instrument AB201541
+5K151561Leksell Gamma Knife IconElekta Instrument AB201541
+5K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.2014251
+6K240431ExacTrac Dynamic (2.0); ExacTrac Dynamic SurfaceBrainlab AG20241—
+6K231052ExacTrac Dynamic 1.1.2Brainlab AG20230—
+6K213787Monaco RTP SystemElekta Solutions AB20222—
+6K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited2021110
+6K192482Elekta UnityElekta Limited201923
+6K191267ImagingRing System on RailsMedphoton GmbH20190—
+6K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB20182—
+6K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc.201723—
+6K160440Leksell Gamma Knife IconElekta Instrument AB201631
+6K150706VitalBeamVarian Medical Systems, Inc.201501
+7K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB20260—
+7K254010ExacTrac Dynamic (2.0.2); ExacTrac Dynamic SurfaceBrainlab SE20260—
+7K223233Monaco RTP SystemElekta Solutions AB20231—
+7K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB20221—
+7K212114Elekta UnityElekta Solutions AB202111
+7K172013VitalBeamVarian Medical Systems, Inc.20175—
+7K171733TrueBeam, TrueBeam STx, EdgeVarian Medical Systems, Inc.20177—
+7K170817HalcyonVarian Medical Systems, Inc.201715—
+8K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+8K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife®…Elekta Solutions AB202501
+8K223209Elekta UnityElekta Solutions AB20230—
+8K213977TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20224—
+8K210894Siddharth-II; ImpactPanacea Medical Technologies Pvt., Ltd.20211—
+8K181032HalcyonVarian Medical Systems, Inc.201814—
+9K231317TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20232—
+9K222762Siddharth-II;ImpactPanacea Medical Technologies Pvt., Ltd.20230—
+9K223839TrueBeam, TrueBeam STx, Edge, VitalBeamVarian Medical Systems, Inc.20230—
+9K193207TaiChiAOur United Corporation20201—
+9K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+10K232870TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1)Varian Medical Systems, Inc.20231—
+10K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+10K210921TaiChiBOur United Corporation20210—
+10K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+11K252948TrueBeam, TrueBeam STX, Edge and VitalBeamVarian Medical Systems, Inc.20250—
+11K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+11K232479ART-PlanTherapanacea20232—
+11K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+12K253078ART.1-USSeetreat Pty, Ltd.20260—
+12K252977Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.20261—
+12K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—