510(k) Report

Devices descending from K941223

478 later devices reach Advance Analysis Software through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983256Advantage Windows (AW) FusionGE Medical Systems1998477—
+2K093234Integrated RegistrationGE Medical Systems SCS20090—
+2K063324Pet VcarGE Healthcare20072041
+2K022310Advantage Windows X-Ray/MR FusionGe Medical Systems, Inc.20021—
+2K021191AutoalignCortechs Labs, Inc.20020—
+2K020546Fusion 7DMirada Solutions, Ltd.2002442—
+2K013673HI-Art SystemTomo Therapy, Inc.200227—
+3K211247Pet VcarGE Medical Systems SCS20211—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+3K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+3K061214Aquariusaps ServerTerarecon,Inc.2006134—
+3K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+3K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+3K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+3K041286Dynacad V1.0Mri Devices Corp.200417—
+3K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+3K033347Modification to: HI-Art SystemTomotherapy Incorporated200326—
+3K031779CadstreamConfirma, Inc.200319—
+4K251883MIM – LesionID ProMim Software, Inc.20250—
+4K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+4K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+4K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+4K173744ProFuse CADEigen20181—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K151115MR Core SoftwareVital Images, Inc.20153—
+4K132853NovapacsNovarad Corp.201462
+4K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+4K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+4K121916IntuitionTerarecon,Inc.201351
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+4K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+4K110919Carestream PacsCarestream Health, Inc.2011850
+4K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+4K110256The IC-Pro SystemPaieon, Inc.201115—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K100094Carestream Image SuiteCarestream Heatlh, Inc.201022
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+4K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+4K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+4K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+4K063031Prism View, ModelKyron Clinical Imaging, Inc.20062—
+4K060453Aze VirtualplaceAze, Ltd.20061—
+4K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+4K042739HI-Art SystemTomotherapy Incorporated200425—
+4K041020Cadstream Version 3.1Confirma, Inc.20040—
+5K240822Image Management V15Philips Medical Systems Technologies20240—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K202700ART-PlanTherapanacea20215—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K200323AutoContourRadformation, Inc.20207—
+5K200274CariCloudCaristo Diagnostics20200—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K173312ProBx SoftwareHarmonus, Inc.20180—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K160371NovaPACSNovarad Corporation20165—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K161419Multi Modality ViewerVital Images, Inc.20162—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K151283Lung Analysis SoftwareVital Images, Inc.20158—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc.20141—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc.20146—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K120282CardnavPaieon, Inc.20120—
+5K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+5K113620Myrian 1.11Intrasense20126—
+5K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—