510(k) Report

Devices descending from K926008

137 later devices reach Pinnacle 3 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993675Peregrine Radiation Therapy Dose Calculation SystemNomos Corp.200014—
+1K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories200079—
+1K970236Theraplan Plus Version 1.2Theratronics, Inc.199765—
+1K951581PINNACLE3 ApexAdac Laboratories199683—
+2K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090—
+2K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+2K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc.20040—
+2K032724PINNACLE3 Radiation Therapy Planning SystemAdac Laboratories2003441
+2K031349OTP 1.2Nucletron Corp.200359—
+2K013673HI-Art SystemTomo Therapy, Inc.200227—
+2K013112Focal SimComputerized Medical Systems, Inc.20014710
+2K993359Raptor Treatment Planning SystemNomos Corp.19990—
+2K973936Focus RTP SystemComputerized Medical Systems, Inc.19981—
+2K980379Prowess Pro-SimSsgi Prowess Systems19983—
+2K964206Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2Nucletron Corp.19971—
+3K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+3K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation2008542
+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—
+3K032456ProwessProwess, Inc.20030—
+3K022036Siemens Virtual Simulation (Vsim)Siemens Medical Solutions USA, Inc.200232—
+3K992689MU PlusRad Therapy Solutions, Inc.20000—
+3K984196Modification to Prowess Pro-SimSsgi Prowess Systems19980—
+3K980629VSS, Virtual Simulation SystemNucletron Corp.19980—
+4K121448Oncentra, Oncentra External Beam, Oncentra BrachyElekta Inc. D/B/A Nucletron Corporation201293
+4K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+4K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+4K100552Raystation Version 1.0Raysearch Laboratories AB2010304
+4K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+4K090808PINNACLE3 SmartarcPhilips Medical Systems, Inc.200901
+4K083264Rayautoplan 1.0Raysearch Laboratories AB2009312
+4K082642Oncentra RT Viewer 1.0Nucletron Corporation20080—
+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
+5K193459Panther StereotacticProwess, Inc.20201—
+5K132816Oncentra BrachyNucletron B.V.201403
+5K132971MonacoImpac Medical Systems, Inc.201374
+5K120387RaystationRaysearch Laboratories AB2012226
+5K112060RadianceGmv Aerospace and Defence S.A.20126—
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K103093Leksell GammaplanElekta Instrument AB201051
+5K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+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—
+6K231825Panther TPSProwess, Inc.20230—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+6K151666Leksell GammaPlanElekta Instrument AB201541
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K140187Ray StationRaysearch Laboratories AB2014191
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K133655Radiance V2Gmv Soluciones Globales Internet S.A.U.20145—
+6K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+6K130617RaystationRaysearch Laboratories AB2013216
+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—
+6K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+6K102671Syngo RT Therapist Connect Workspace, V4.2Siemens Medical Solutions USA, Inc.20105—
+6K092145160MLC OptionSiemens Medical Solutions USA, Inc.2009411
+6K090683Syngo RT Therapist ConnectSiemens Medical Solutions USA, Inc.200974
+6K083502Panther Realart, Model 4.7Prowess, Inc.20090—
+6K082775Prescision OptionSiemens Medical Solutions USA, Inc.20099—
+6K082005Modification to HI-Art Treatment SystemTomotherapy Incorporated2008137
+6K072485Artiste MV SASiemens Medical Solutions USA, Inc.20071124
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K173940Astroid Planning App.Decimal, LLC20180—
+7K173791Leksell GammaPlanElekta Instrument AB201832
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+7K151435MRCATPhilips Medical Systems MR Finland20164—
+7K153368Radiance V3Gmv Soluciones Globales Internet S.A.U.20164—
+7K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+7K141860RaystationRaysearch Laboratories AB2014175
+7K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+7K112776Tomotherapy Treatment System Fast OptimizerTomotherapy Incorporated201111—
+7K112446Tomotherapy Treatment SystemTomotherapy Incorporated20110—
+7K100096Linac Collimator Assembly Housing (Lcah) Model LcahartIntegra Radionics, Inc.20100—
+8K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+8K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+8K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+8K171885Radiance V4Gmv Soluciones Globales Internet S.A.U.20173—
+8K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+8K121934Tomotherapy Treatment SystemAccuray Incorporated2012108
+9K233236Radiance V5Gmv Soluciones Globales Internet S.A.U.20240—