510(k) Report

Devices descending from K982821

165 later devices reach MMS Therpacplus B3DTUI Model Number 6.7 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030534Variseed 7.1Varian Medical Systems2003831
+1K012017Variseed 7.0Varian Medical Systems20011—
+1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079—
+2K143514Panther StereoSeedProwess, Inc.20150—
+2K150636VariSeed 9.0Varian Medical Systems, Inc.20151—
+2K131428RadvisionAcoustic Medsystems, Inc.20130—
+2K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+2K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090—
+2K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc.20040—
+2K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories2003441
+2K013673HI-Art SystemTomo Therapy, Inc.200227—
+2K013112Focal SimComputerized Medical Systems, Inc.20014710
+3K232400VariSeed (v10)Varian Medical Systems20230—
+3K190379MIM on LinuxMim Software, Inc.201914—
+3K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+3K173420Radiomics App v1.0Microsoft Corp.20174—
+3K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+3K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+3K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp.20060—
+3K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP20041—
+3K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories2004397
+3K033347Modification to: HI-Art SystemTomotherapy Incorporated200326—
+3K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.200232—
+4K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+4K223800MIM – Additional TracersMim Software, Inc.20231—
+4K220256MIM-AblationMim Software, Inc.20224—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K201232Limbus ContourLimbus Ai, Inc.20202—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K182624MIM - MRT DosimetryMim Software, Inc.201853—
+4K182016Simplicit90YMirada Medical, Ltd.20183—
+4K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+4K173636VelocityVarian Medical Systems, Inc.20188—
+4K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+4K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+4K082221RaydoseRaysearch Laboratories AB20080—
+4K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc.200829—
+4K061893Integra Radionics Xknife RT 4Integra Radionics, Inc.20060—
+4K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc.2006191
+4K042739HI-Art SystemTomotherapy Incorporated200425—
+4K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc.20031617
+5K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+5K232514MIM – Dose AnalysisMim Software, Inc.20240—
+5K230575Limbus ContourLimbus Ai, Inc.20231—
+5K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+5K210632Contour ProtegeAIMim Software, Inc.20215—
+5K203235VBrainVysioneer, Inc.20214—
+5K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+5K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+5K191610RTappSegana, LLC20191—
+5K182966PLANET Onco DoseDosisoft20191—
+5K182855ProKnow DSProknow, LLC20192—
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+5K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+5K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K060633Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Siemens Medical Solutions USA, Inc.200651
+5K060912Modification to: HI-Art SystemTomotherapy Incorporated2006244
+5K060226Oncor ExpressionSiemens Medical Solutions USA, Inc.20061372
+5K052315Simtec IM-Maxx 2 OptionSiemens Medical Solutions USA, Inc.20054—
+6K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+6K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+6K252922Neosoma Brain MetsNeosoma, Inc.20250—
+6K251363ProKnow DSElekta Solutions AB20250—
+6K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+6K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K241837Limbus ContourLimbus Ai, Inc.20240—
+6K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+6K230082Auto SegmentationGe Medical Systems, LLC20231—
+6K221706AccuContourManteia Technologies Co., Ltd.20232—
+6K220630TorchTM SoftwareVoximetry, Incorporated20221—
+6K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K213628VBrainVysioneer, Inc.20210—
+6K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+6K212887RTappSegana, Inc.20210—
+6K212116VBrain-OARVysioneer, Inc.20211—
+6K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+6K202700ART-PlanTherapanacea20215—
+6K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+6K193459Panther StereotacticProwess, Inc.20201—
+6K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K132971MonacoImpac Medical Systems, Inc.201374
+6K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+6K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+6K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—