510(k) Report

Devices descending from K002509

88 later devices reach Novalis (Shaped Beam Surgery System) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033343Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc.2003873
+2K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc.2007785
+2K061140Trilogy Radiotherapy Delivery SystemVarian Medical Systems200686—
+3K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+3K072916Trilogy System with RapidarcVarian Medical Systems, Inc.2007772
+3K062618Trilogy TX with 3RD Party Couch Top SupportVarian Medical Systems, Inc.20060—
+4K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+4K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+4K101751Varian Unique Single Energy Linear AcceleratorVarian Medical Systems, Oncology Systems201031
+4K100890Varian High Energy Linear AcceleratorVarian Medical Systems2010411
+4K092871Trilogy MXVarian Medical Systems, Inc.2009615
+4K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+4K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+4K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+4K081188Trilogy with External System Gating InterfaceVarian Medical Systems, Inc.200861
+5K232489VenusXLinatech, LLC20240—
+5K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+5K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+5K132705UniqueVarian Medical Systems, Inc.201311
+5K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+5K111862Viewray SystemViewray, Incorporated201299
+5K112839Varian High Energy Linear AcceleratorVarian Medical Systems201131
+5K111106TruebeamVarian Medical Systems, Inc.2011435
+5K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+5K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+5K083414Radionics Xknife HDRT SystemIntegra Radionics, Inc.20090—
+6K183037Monaco RTP SystemElekta, Inc.201856
+6K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+6K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorVarian Medical Systems, Inc.201801
+6K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+6K131807High Energy Linear AcceleratorVarian Medical Systems, Inc.201322
+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
+7K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc.20161—
+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—