510(k) Report

Devices descending from K043441

98 later devices reach Mirage, Release 5.5 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123528SceniumSiemens Medical Solutions USA, Inc.201279—
+1K121074Scenium 2.0Siemens Medical Solutions USA, Inc.201290—
+1K080013Registration and FusionAgfa Healthcare Corporation20085—
+1K061545Scenium 1.1Siemens Molecular Imaging, Ltd.200691—
+2K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+2K140269Hermes Medical Imaging Suite V5.4Hermes Medical Solutions AB201415—
+2K133135Impax Volume Viewing 3.0Agfa Healthcare N.V.20143—
+2K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+2K130451Neuroq 3.6Syntermed, Inc.20131—
+2K130884Xeleris 3.1 Processing and Review WorkstationGe Medical Systems F.I. Haifa201377—
+2K111638Impax Volume ViewingAgfa Healthcare N.V.20114—
+3K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+3K221405Neurophet SCALE PETNeurophet., Inc.20222—
+3K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+3K180077NeuroQ 3.8Syntermed20180—
+3K171681Hermes Medical Imaging Suite v5.7Hermes Medical Solutions AB201721
+3K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K153056Hermes Medical Imaging Suite v5.6Hermes Medical Solutions AB201610—
+3K153355Xeleris 4.0 Processing and Review WorkstationGE Healthcare201660—
+3K152822VidiStar HeartViewVidistar, LLC20150—
+3K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+3K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+3K142631Hermes Medical Imaging Suite v5.5Hermes Medical Solutions AB201411—
+4K252563Neurophet SCALE PETNeurophet., Inc.20260—
+4K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+4K241364Hybrid Viewer (00859873006189)Hermes Medical Solutions AB20241—
+4K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+4K182624MIM - MRT DosimetryMim Software, Inc.201853—
+4K171719Hybrid3DHermes Medical Solutions AB20175—
+4K163394Hybrid3DHermes Medical Solutions AB20176—
+4K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+5K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+5K233908cNeuro cDATCombinostics OY20240—
+5K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+5K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+5K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K203235VBrainVysioneer, Inc.20214—
+5K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+5K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+5K190379MIM on LinuxMim Software, Inc.201914—
+5K181468Hybrid3DHermes Medical Solutions AB20184—
+5K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+6K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+6K252922Neosoma Brain MetsNeosoma, Inc.20250—
+6K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+6K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+6K241350Clarify DLGe Medical Systems Israel, Functional Imaging20250—
+6K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+6K230082Auto SegmentationGe Medical Systems, LLC20231—
+6K221706AccuContourManteia Technologies Co., Ltd.20232—
+6K223800MIM – Additional TracersMim Software, Inc.20231—
+6K220630TorchTM SoftwareVoximetry, Incorporated20221—
+6K220256MIM-AblationMim Software, Inc.20224—
+6K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+6K213628VBrainVysioneer, Inc.20210—
+6K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+6K212116VBrain-OARVysioneer, Inc.20211—
+6K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+6K202700ART-PlanTherapanacea20215—
+6K202882AffinityHermes Medical Solutions AB20201—
+6K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+6K202392SIR-Spheres Microspheres Activity Calculator (SMAC)Sirtex Medical US Holdings, Inc.20200—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K193152AffinityHermes Medical Solutions AB20200—
+7K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+7K253835AffinityHermes Medical Solutions AB20260—
+7K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+7K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+7K242925MR Contour DLGE Healthcare20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+7K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+7K232514MIM – Dose AnalysisMim Software, Inc.20240—
+7K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+7K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+7K220813Art-PlanTherapanacea20224—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+8K251306Seg Pro V3 (RT-300)Ever Fortune.Ai, Co., Ltd.20260—
+8K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+8K232928DeepContour (V1.0)Wisdom Technologies., Inc.20240—
+8K232899AI-Rad Companion Organs RTSiemens Medical Solutions U.S.A.20243—
+8K230023ART-PlanTherapanacea Sas20233—
+8K213976Contour ProtégéAIMim Software, Inc.20224—
+9K251883MIM – LesionID ProMim Software, Inc.20250—
+9K242745AI-Rad Companion Organs RTSiemens Healthcare GmbH20252—
+9K232479ART-PlanTherapanacea20232—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+10K261306AI Contouring (VA10A)Varian Medical Systems20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K252548AI-Rad Companion Organs RTSiemens Healthcare GmbH20260—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+11K250035Contour ProtégéAI+Mim Software, Inc.20251—
+12K253270Contour ProtégéAI+Mim Software, Inc.20260—