510(k) Report

Devices descending from K033374

295 later devices reach Lungcare CT Software Package with Extended Functionality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042694Advanced Lung Analysis IIGE Medical Systems2004207—
+1K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+1K041484UndecidedSiemens Medical Solutions USA, Inc.2004222—
+1K041807Lung Car 1.1Medicsight2004135—
+1K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+2K120679Synapse 3D Nodule AnalysisFujifilm Medical Systems U.S.A, Inc.20120—
+2K063324Pet VcarGE Healthcare20072041
+2K061372Centricity AW Suite OptionGe Healthcare Information Technologies200602
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+2K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K211247Pet VcarGE Medical Systems SCS20211—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K132853NovapacsNovarad Corp.201462
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K121916IntuitionTerarecon,Inc.201351
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+3K071241LMS-LiverMedian Technologies20079—
+4K251883MIM – LesionID ProMim Software, Inc.20250—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200274CariCloudCaristo Diagnostics20200—
+4K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+4K170195QuantXQuantitative Insights, Inc.20174—
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K160371NovaPACSNovarad Corporation20165—
+4K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K200315Ziostation2Ziosoft, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+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—
+5K171754NovaPACSNovarad Corporation201741
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K113620Myrian 1.11Intrasense20126—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K260086CadAI-B DxBeamWorks, Inc.20260—
+6K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—