510(k) Report

Devices descending from K983256

477 later devices reach Advantage Windows (AW) Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K093234Integrated RegistrationGE Medical Systems SCS20090—
+1K063324Pet VcarGE Healthcare20072041
+1K022310Advantage Windows X-Ray/MR FusionGe Medical Systems, Inc.20021—
+1K021191AutoalignCortechs Labs, Inc.20020—
+1K020546Fusion 7DMirada Solutions, Ltd.2002442—
+1K013673HI-Art SystemTomo Therapy, Inc.200227—
+2K211247Pet VcarGE Medical Systems SCS20211—
+2K151212Ziostation2Qi Imaging, LLC20152—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+2K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+2K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+2K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+2K041286Dynacad V1.0Mri Devices Corp.200417—
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+2K033347Modification to: HI-Art SystemTomotherapy Incorporated200326—
+2K031779CadstreamConfirma, Inc.200319—
+3K251883MIM – LesionID ProMim Software, Inc.20250—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+3K173744ProFuse CADEigen20181—
+3K181892Ziostation2Ziosoft, Inc.20181—
+3K151115MR Core SoftwareVital Images, Inc.20153—
+3K132853NovapacsNovarad Corp.201462
+3K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K121916IntuitionTerarecon,Inc.201351
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K110919Carestream PacsCarestream Health, Inc.2011850
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K100094Carestream Image SuiteCarestream Heatlh, Inc.201022
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+3K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+3K063031Prism View, ModelKyron Clinical Imaging, Inc.20062—
+3K060453Aze VirtualplaceAze, Ltd.20061—
+3K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+3K042739HI-Art SystemTomotherapy Incorporated200425—
+3K041020Cadstream Version 3.1Confirma, Inc.20040—
+4K240822Image Management V15Philips Medical Systems Technologies20240—
+4K220779XDMirada Medical, Ltd.20220—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K202700ART-PlanTherapanacea20215—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200323AutoContourRadformation, Inc.20207—
+4K200274CariCloudCaristo Diagnostics20200—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K173312ProBx SoftwareHarmonus, Inc.20180—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K160371NovaPACSNovarad Corporation20165—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K161419Multi Modality ViewerVital Images, Inc.20162—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K151283Lung Analysis SoftwareVital Images, Inc.20158—
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc.20141—
+4K133993Caas WorkstationPie Medical Imaging201410—
+4K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc.20146—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K120282CardnavPaieon, Inc.20120—
+4K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+4K113620Myrian 1.11Intrasense20126—
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K113594C-THV SystemPaieon, Inc.20120—
+4K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+4K113076Caas a-ValvePie Medical Imaging BV20121—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—