510(k) Report

Devices descending from K914698

124 later devices reach Setup Computer with Software V-1261,62 and 63 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K992689MU PlusRad Therapy Solutions, Inc.20000—
+1K980904Mucheck Monitor Unit Validation ProgramMedical Dosimetry Services, Inc.1998122—
+2K061152Mucheck V7.0Oncology Data Systems, Inc.200621—
+2K012227Mucheck - Monitor Unit Validation Program, Model V4.1Oncology Data Systems, Inc.200140—
+2K990833Dose Calc, Model VS. 1.02Integrity Medical Software, Inc.199980—
+3K091602Mucheck V8Oncology Data Systems, Inc.20091—
+3K090531Radcalc Software, Version 6.0Lifeline Software, Inc.200917—
+3K082773Standard Imaging Imsure Brachy QA Software, Model 91331Standard Imaging, Inc.20080—
+3K072374CompassScanditronix Wellhofer GmbH2007313
+3K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079—
+4K193640ClearCalcRadformation, Inc.20202—
+4K153014Mobius3DMobius Medical Systems, LP201613—
+4K151426ScandiDos Delta4 Discover, Alternative Trade Name: ScandiDos Delta4 Discover+Scandidos AB20161—
+4K141800PerfractionSun Nuclear Corporation20145—
+4K140660MOBIUS3DMobius Medical Systems, LP2014231
+4K1318623DVHSun Nuclear Corporation20130—
+4K102583Mucheck, Version 9.0Oncology Data Systems, Inc.20100—
+4K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090—
+4K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc.20040—
+4K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories2003441
+4K013673HI-Art SystemTomo Therapy, Inc.200227—
+4K013112Focal SimComputerized Medical Systems, Inc.20014710
+5K252258Veriqa RT Epid 3DPtw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla20260—
+5K220582ClearCalc Model RADCA V2Radformation, Inc.20221—
+5K201798myQA iONIba Dosimetry GmbH202011
+5K191761Mobius3DVarian Medical Systems, Inc.20195—
+5K180697Pseudo-PatientRtsafe, Inc.20180—
+5K180595SciMoCaRadialogica, LLC20183—
+5K171350Collision CheckRadformation, Inc.20174—
+5K172534LINACwatch, LinacViewQualiformed Sarl20170—
+5K170307SunCHECKSun Nuclear Corporation20171—
+5K162577Dosimetry Check Version 5 Release 1Math Resolutions, LLC20160—
+5K161946DoseCHECKSun Nuclear Corporation20164—
+5K152994AdaptivoAurora Technology Development, LLC20160—
+5K150848Dose CalculatorSun Nuclear Corporation20150—
+5K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+5K063482Crossplan / Accusoft-XL V.4.04Direx Systems Corp.20060—
+5K041997Radionics Xknife RT 3 with Non Stereotactic ModuleRadionics, A Division of Tyco Healthcare Group LP20041—
+5K041577PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories2004397
+5K033347Modification to: HI-Art SystemTomotherapy Incorporated200326—
+5K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.200232—
+6K260597Virtue QAProNova Solutions20260—
+6K252863ClearCalc Model RADCA V2.6Radformation, Inc.20250—
+6K223234Delta4 InsightScandidos AB20240—
+6K231273ArcherQA (V1.0)Wisdom Technologies., Inc.20240—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K213137INTDoseCarina Medical, LLC20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+6K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+6K082221RaydoseRaysearch Laboratories AB20080—
+6K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc.200829—
+6K061893Integra Radionics Xknife RT 4Integra Radionics, Inc.20060—
+6K061097Coherence Dosimetrist, Model 2.2Siemens Medical Solutions USA, Inc.2006191
+6K042739HI-Art SystemTomotherapy Incorporated200425—
+6K031764Oncor Avant-Garde with Coherence WorkspacesSiemens Medical Solutions USA, Inc.20031617
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K231185MapRTVision Rt, Ltd.20231—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+7K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+7K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+7K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+7K060633Coherence Oncologist Workspace, Model 2.0 and Physicist Workspace, Model 1.0Siemens Medical Solutions USA, Inc.200651
+7K060912Modification to: HI-Art SystemTomotherapy Incorporated2006244
+7K060226Oncor ExpressionSiemens Medical Solutions USA, Inc.20061372
+7K052315Simtec IM-Maxx 2 OptionSiemens Medical Solutions USA, Inc.20054—
+8K243301MapRTVision Rt, Ltd.20250—
+8K250099Mobius3D (4.1)Varian Medical Systems20250—
+8K223834AccuCheckManteia Technologies Co., Ltd.20231—
+8K193459Panther StereotacticProwess, Inc.20201—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+8K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K132971MonacoImpac Medical Systems, Inc.201374
+8K123812Coherence RT Therapist Connect Workspace, V2.3, Aria Connectivity Option for Siemens…Siemens Medical Solutions USA, Inc.201339
+8K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+8K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+8K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+8K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+8K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+8K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+8K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+8K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+8K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+8K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+8K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated2008137
+8K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+9K250696AccuCheckManteia Technologies Co., Ltd.20250—
+9K231825Panther TPSProwess, Inc.20230—
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+9K151233MonacoImpac Medical Systems, Inc.201569
+9K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+9K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+9K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+9K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+9K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+10K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962