510(k) Report

Devices descending from K020546

442 later devices reach Fusion 7D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+1K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+1K061214Aquariusaps ServerTerarecon,Inc.2006134—
+1K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+1K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+1K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+1K041286Dynacad V1.0Mri Devices Corp.200417—
+1K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+1K031779CadstreamConfirma, Inc.200319—
+2K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+2K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+2K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+2K173744ProFuse CADEigen20181—
+2K151115MR Core SoftwareVital Images, Inc.20153—
+2K132853NovapacsNovarad Corp.201462
+2K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+2K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+2K121916IntuitionTerarecon,Inc.201351
+2K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+2K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+2K110919Carestream PacsCarestream Health, Inc.2011850
+2K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+2K110256The IC-Pro SystemPaieon, Inc.201115—
+2K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+2K100094Carestream Image SuiteCarestream Heatlh, Inc.201022
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+2K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+2K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+2K081556Cadstream, Version 5.0Confirma, Inc.20099—
+2K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+2K063031Prism View, ModelKyron Clinical Imaging, Inc.20062—
+2K060453Aze VirtualplaceAze, Ltd.20061—
+2K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+2K041020Cadstream Version 3.1Confirma, Inc.20040—
+3K240822Image Management V15Philips Medical Systems Technologies20240—
+3K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+3K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+3K200274CariCloudCaristo Diagnostics20200—
+3K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+3K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K173312ProBx SoftwareHarmonus, Inc.20180—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+3K160371NovaPACSNovarad Corporation20165—
+3K161419Multi Modality ViewerVital Images, Inc.20162—
+3K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+3K151283Lung Analysis SoftwareVital Images, Inc.20158—
+3K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc.20141—
+3K133993Caas WorkstationPie Medical Imaging201410—
+3K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc.20146—
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K120282CardnavPaieon, Inc.20120—
+3K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+3K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+3K113594C-THV SystemPaieon, Inc.20120—
+3K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+3K113076Caas a-ValvePie Medical Imaging BV20121—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+3K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+3K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+3K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+3K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+3K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+4K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+4K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+4K251168Image SuiteCarestream Health, Inc.20250—
+4K251484CT:VQ4Dmedical Limited20250—
+4K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K223261Open RibCanon Medical Informatics, Inc.20230—
+4K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+4K220349TeraRecon NeuroTerarecon,Inc.20220—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K220779XDMirada Medical, Ltd.20220—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+4K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+4K202700ART-PlanTherapanacea20215—
+4K200323AutoContourRadformation, Inc.20207—
+4K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+4K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+4K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—