510(k) Report

Devices descending from K920879

65 later devices reach Brainscan Radiosurgery Module through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K994413BrainscanBrainlab AG2000641
+2K080888Modeification to Iplan RT DoseBrainlab AG2008333
+2K053584Iplan RT DoseBrainlab AG2006603
+2K032511Intuition ImageBrainlab AG200435—
+3K103246Iplan RTBrainlab AG2011322
+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—
+4K142108RT Elements, Dose Review, Brain Metastases, Adaptive Hybrid Surgery AnalysisBrainlab AG201453
+4K120387RaystationRaysearch Laboratories AB2012226
+4K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+4K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K223279RT Elements (4.0)Brainlab AG20231—
+5K202284OncospaceOncospace, Inc.20214—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K151887syngo VSimSiemens Medical Solutions USA, Inc.20158—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+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—
+6K222803OncospaceOncospace, Inc.20233—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K151233MonacoImpac Medical Systems, Inc.201569
+6K150547.decimal Astroid Dosimetry App.Decimal, Inc.20150—
+6K140187Ray StationRaysearch Laboratories AB2014191
+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—
+7K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+7K183037Monaco RTP SystemElekta, Inc.201856
+7K173940Astroid Planning App.Decimal, LLC20180—
+7K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+7K141860RaystationRaysearch Laboratories AB2014175
+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—
+8K160093RayStationRaySearch Laboratories AB (PUBL)2016167
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202789Monaco Rtp SystemElekta Solutions AB20213—
+9K170355RayStation 6RaySearch Laboratories AB (PUBL)2017151
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K213787Monaco RTP SystemElekta Solutions AB20222—
+10K170750RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid…Brainlab AG201701
+10K171536RayStationRaySearch Laboratories AB (PUBL)2017136
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K223233Monaco RTP SystemElekta Solutions AB20231—
+11K180379RayStation 7RaySearch Laboratories AB (PUBL)2018127
+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—
+12K190387RayStationRaySearch Laboratories AB (PUBL)20191132
+13K200569RayStationRaySearch Laboratories AB (PUBL)2020614
+14K210645RayStation 10.1RaySearch Laboratories AB (PUBL)202156
+15K211867RayStation 11.0RaySearch Laboratories AB (PUBL)202148
+16K220141RayStation 11BRaySearch Laboratories AB (PUBL)202236
+17K222312RayStation 12ARaySearch Laboratories AB (PUBL)202326
+18K240398RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3…RaySearch Laboratories AB (PUBL)202512
+19K252109RayStation (2024A SP3)RaySearch Laboratories AB (PUBL)20250—