510(k) Report

Devices descending from K001643

183 later devices reach Varis 1.4G through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K0504794D Integrated Treatment ConsoleVarian Medical Systems2005722
+1K042956VisionVarian Medical Systems, Inc.2005121—
+2K112930Mobile MimMim Software, Inc.201199—
+2K093967Varian TreatmentVarian Medical Systems, Inc.201011
+2K093527Aria Radiation Oncology with MirsVarian Medical Systems, Inc.2009299
+2K0911324D Integrated Treatment ConsoleVarian Medical Systems200955
+2K0810364D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Varian Medical Systems, Inc.2008693
+2K052391Vision (with Off-Line Review)Varian Medical Systems20050—
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+3K151882Varian Treatment (VTx)Varian Medical Systems, Inc.20150—
+3K142196Visage Ease ProVisage Imaging GmbH20150—
+3K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+3K142268Varian Verification System (VVS)Varian Medical Systems, Inc.20140—
+3K133572Aria Radiation Therapy ManagementVarian Medical Systems, Inc.2014201
+3K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+3K1333314D Integrated Treatment ConsoleVarian Medical Systems, Inc.201411
+3K123357Onq RTSOncology Systems, Inc.20120—
+3K122616Panther Ois/R & V Model Version 2.0Prowess, Inc.20121—
+3K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+3K120067Mosaiq Oncology Information SystemImpac Medical Systems, Inc.201283
+3K103394Barcode Conical Collimator Verification (BCCV)Varian Medical Systems, Oncology Systems201111
+3K092871Trilogy MXVarian Medical Systems, Inc.2009615
+4K211760Panther OISProwess, Inc.20210—
+4K2037664D Integrated Treatment ConsoleVarian Medical Systems, Inc.20210—
+4K180106ThinkQADosisoft20180—
+4K173838ARIA Radiation Therapy ManagementVarian Medical Systems, Inc.2018181
+4K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+4K161130ResolutionMDCalgary Scientific, Inc.20164—
+4K142142Quality ReportsSun Nuclear Corporation20145—
+4K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+4K111862Viewray SystemViewray, Incorporated201299
+4K111106TruebeamVarian Medical Systems, Inc.2011435
+4K102915Viewray Treatment Planning and Delivery SystemViewray, Incorporated2011151
+5K260500ResolutionMDResolutionMD, Inc.20260—
+5K221408ARIA Radiation Therapy Management (v16.1 MR3)Varian Medical Systems, Inc.20223—
+5K221448ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8)Varian Medical Systems, Inc.20220—
+5K201119ChartCheckRadformation, Inc.20201—
+5K192377Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, HalcyonVarian Medical Systems, Inc.20209—
+5K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+5K182624MIM - MRT DosimetryMim Software, Inc.201853—
+5K182016Simplicit90YMirada Medical, Ltd.20183—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+5K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+5K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+5K173636VelocityVarian Medical Systems, Inc.20188—
+5K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+5K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated20178—
+5K162468ClearCheckRadformation20164—
+5K123808AgilityElekta, Ltd.2013362
+5K123291TruebeamVarian Medical Systems, Inc.201237—
+6K252988ChartCheck (RADCH V1.6)Radformation, Inc.20260—
+6K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+6K230699ARIA Radiation Therapy Management (v18.0)Varian Medical Systems, Inc.20232—
+6K222941Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20233—
+6K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+6K212294Ethos Treatment Management, Ethos Treatment PlanningVarian Medical Systems, Inc.20214—
+6K203235VBrainVysioneer, Inc.20214—
+6K203172MOSAIQ Oncology Information SystemElekta Solutions AB202081
+6K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+6K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+6K191610RTappSegana, LLC20191—
+6K191384RayCare 2.3RaySearch Laboratories AB (PUBL)20192—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K190379MIM on LinuxMim Software, Inc.201914—
+6K182966PLANET Onco DoseDosisoft20191—
+6K181989MRIdian Linac SystemViewray, Incorporated201912
+6K182855ProKnow DSProknow, LLC20192—
+6K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited20183—
+6K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated201774
+6K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc.2014312
+6K131965XVI R5.0Elekta Limited20138—
+7K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K242463ARIA Radiation Therapy Management System (18.1)Varian Medical Systems, Inc.20241—
+7K232923Ethos Treatment Management (3.0); Ethos Treatment Planning (2.0)Varian Medical Systems, Inc.20240—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K232479ART-PlanTherapanacea20232—
+7K232113Halcyon, Ethos Radiotherapy SystemVarian Medical Systems, Inc.20232—
+7K231185MapRTVision Rt, Ltd.20231—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K223229MOSAIQ® OIS (Oncology Information System)Elekta Solutions AB202304
+7K223800MIM – Additional TracersMim Software, Inc.20231—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220256MIM-AblationMim Software, Inc.20224—
+7K213526Aurora-RTMagnettx Oncology Solutions, Ltd.20220—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K212958MRIdian Linac SystemViewray, Incorporated20210—
+7K212887RTappSegana, Inc.20210—