510(k) Report

Devices descending from K061545

91 later devices reach Scenium 1.1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290—
+2K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+2K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+2K123528SceniumSiemens Medical Solutions USA, Inc.201279—
+3K221405Neurophet SCALE PETNeurophet., Inc.20222—
+3K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+3K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+3K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+3K130451Neuroq 3.6Syntermed, Inc.20131—
+3K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+4K252563Neurophet SCALE PETNeurophet., Inc.20260—
+4K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+4K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+4K180077NeuroQ 3.8Syntermed20180—
+4K171681Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB201721
+4K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB201610—
+4K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare201660—
+4K152822VidiStar HeartViewVidistar, LLC20150—
+4K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB201411—
+5K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+5K182624MIM - MRT DosimetryMim Software, Inc.201853—
+5K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+5K171719Hybrid3DHermes Medical Solutions AB20175—
+5K163394Hybrid3DHermes Medical Solutions AB20176—
+6K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+6K233908cNeuro cDATCombinostics OY20240—
+6K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+6K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+6K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K203235VBrainVysioneer, Inc.20214—
+6K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+6K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+6K190379MIM on LinuxMim Software, Inc.201914—
+6K181468Hybrid3DHermes Medical Solutions AB20184—
+7K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K223800MIM – Additional TracersMim Software, Inc.20231—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220256MIM-AblationMim Software, Inc.20224—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K212116VBrain-OARVysioneer, Inc.20211—
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K202700ART-PlanTherapanacea20215—
+7K202882AffinityHermes Medical Solutions AB20201—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.20200—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K193152AffinityHermes Medical Solutions AB20200—
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+8K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+8K242925MR Contour DLGE Healthcare20250—
+8K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+8K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+8K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+8K232514MIM – Dose AnalysisMim Software, Inc.20240—
+8K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+8K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+8K220813Art-PlanTherapanacea20224—
+8K210632Contour ProtegeAIMim Software, Inc.20215—
+9K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+9K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+9K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+9K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+9K230023ART-PlanTherapanacea Sas20233—
+9K213976Contour ProtégéAIMim Software, Inc.20224—
+10K251883MIM – LesionID ProMim Software, Inc.20250—
+10K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+10K232479ART-PlanTherapanacea20232—
+10K223774Contour ProtégéAIMim Software, Inc.20233—
+11K261306AI Contouring (VA10A)Varian Medical Systems20260—
+11K253078ART.1-USSeetreat Pty, Ltd.20260—
+11K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+11K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+11K231765Contour ProtégéAIMim Software, Inc.20232—
+12K250035Contour ProtégéAI+Mim Software, Inc.20251—
+13K253270Contour ProtégéAI+Mim Software, Inc.20260—