510(k) Report

Devices descending from K971367

95 later devices reach Brainscan Conformal RT Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032762Xio Radiation Treatment Planning SystemComputerized Medical Systems, Inc.200352—
+1K994413BrainscanBrainlab AG2000641
+2K092132Xio RTP SystemComputerized Medical Systems, Inc.20093412
+2K080888Modeification to Iplan RT DoseBrainlab AG2008333
+2K071938Monaco RTP SystemComputerized Medical Systems, Inc.2007135
+2K053584Iplan RT DoseBrainlab AG2006603
+2K061440P.D.Decimal, Inc.20068—
+2K032511Intuition ImageBrainlab AG200435—
+3K103246Iplan RTBrainlab AG2011322
+3K103093Leksell GammaplanElekta Instrument AB201051
+3K102216Xio RTP SystemComputerized Medical Systems, Inc.2010277
+3K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc.2009125
+3K083672P.D Software.Decimal, Inc.20097—
+3K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc.200829—
+3K080886Iplan RT ImageBrainlab AG200833—
+3K052220Iplan RT FibertrackingBrainlab AG200534—
+4K203681RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT…Brainlab AG20212—
+4K151666Leksell GammaPlanElekta Instrument AB201541
+4K151369.decimal p.d.Decimal, LLC20156—
+4K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+4K140187Ray StationRaysearch Laboratories AB2014191
+4K130992PINNACLE3 Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201361
+4K120387RaystationRaysearch Laboratories AB2012226
+4K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+4K110730Monaco RTP SystemComputerized Medical Systems, Inc.201186
+4K101076Prowess Panther Proarc, Model Version 5.0Prowess, Inc.20102—
+4K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K223279RT Elements (4.0)Brainlab AG20231—
+5K202284OncospaceOncospace, Inc.20214—
+5K193459Panther StereotacticProwess, Inc.20201—
+5K192554decimal3D.Decimal, LLC20190—
+5K1802893D Bolus Software3D Bolus, Inc.20184—
+5K173940Astroid Planning App.Decimal, LLC20180—
+5K173791Leksell GammaPlanElekta Instrument AB201832
+5K170086Pinnacle Radiation Therapy Planning SystemPhilips Medical Systems (Cleveland), Inc.201703
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K151435MRCATPhilips Medical Systems MR Finland20164—
+5K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K141860RaystationRaysearch Laboratories AB2014175
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K132971MonacoImpac Medical Systems, Inc.201374
+5K130617RaystationRaysearch Laboratories AB2013216
+5K121075Nervevision Software Systems3D Imaging Partners, Inc.20120—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K103606Artiste Solution with Sys_VB50 UpdateSiemens Medical Solutions USA, Inc.201147
+6K250440RT Elements (4.5); (Elements) Multiple Brain Mets SRS; (Elements) Cranial SRS…Brainlab AG20250—
+6K232854Leksell GammaPlan (LGP)Elekta Solutions AB20240—
+6K231825Panther TPSProwess, Inc.20230—
+6K222803OncospaceOncospace, Inc.20233—
+6K2134383D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D…Adaptiiv20223—
+6K182888MRCAT PelvisPhilips Medical Systems MR Finland20193—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+6K132935Artiste Solution with Sys_VC10C and Syngo RT Therapist Workspace, V4.3.1 Upgrade Kit…Siemens Medical Solutions USA, Inc.20142—
+6K121295Artistetm Solution with Sys VcioSiemens Medical Solutions USA, Inc.201235
+7K253050RadOncAIInformai20260—
+7K250064Dose+ (1.0)Mvision AI OY20250—
+7K242748OncospaceOncospace, Inc.20250—
+7K243057TrueFit Bolus; TrueFlex BolusAdaptiiv Medical Technologies, Inc.20241—
+7K241318Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)Adaptiiv Medical Technologies, Inc.20240—
+7K193109MRCAT brainPhilips Medical Systems MR Finland20202—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+8K260308TrueFit BolusAdaptiiv Medical Technologies, Inc.20260—
+8K211841MRI PlannerSpectronic Medical AB20220—
+8K214081MRCAT Head & NeckPhilips OY20220—
+8K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+8K190178Monaco RTP SystemElekta, Inc.201945
+8K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+8K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+8K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K252002Monaco RTP System (6.3)Elekta Solutions AB20260—
+12K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+13K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+14K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+15K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+16K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+17K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—