510(k) Report

Devices descending from K923524

228 later devices reach Volumetric Rendering Technique Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K030982Syngo Colonography Software PackageSiemens Medical Solutions USA, Inc.2003227—
+2K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+2K090220Colon View, Model CSCV-001AToshibamedical Systems Corporation20090—
+2K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+2K042605Colongraphy Software Package with Extended FunctionalitySiemens AG Medical Solutions200476—
+2K033102Medic Colon Model, Release 1Medicsight2003210—
+3K140920Syngo.CT ColonographySiemens Medical Solutions USA, Inc.20140—
+3K083423Coloncad Api 3.1Medicsight Plc201170—
+3K091529Icad Veralook CTC Cad SoftwareIcad, Inc.20102—
+3K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+3K042674Colon Car 1.2Medicsight2004209—
+4K173744ProFuse CADEigen20181—
+4K122536Amcad-UT Detection Model 2.0Lin & Associates, LLC201369—
+4K081556Cadstream, Version 5.0Confirma, Inc.20099—
+4K061214Aquariusaps ServerTerarecon,Inc.2006134—
+5K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+5K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+5K191278Rsi-Mri+Multimodal Imaging Services Corporation (Dba Healthlytix)20190—
+5K180006AmCAD-UT Detection 2.2Amcad Biomed Corporation20183—
+5K170195QuantXQuantitative Insights, Inc.20174—
+5K162094RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201664—
+5K132853NovapacsNovarad Corp.201462
+5K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+5K121916IntuitionTerarecon,Inc.201351
+5K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+5K092954Cadstream Version 5Confirma, Inc.200983
+6K231130TumorSight VizSimBioSys, Inc.20232—
+6K210670BU-CADTaihao Medical, Inc.20213—
+6K203555AmCAD-UTAmcad Biomed Corporation20212—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+6K200274CariCloudCaristo Diagnostics20200—
+6K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K171048RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201750—
+6K171070WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201742—
+6K170493HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201737—
+6K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201758—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K160371NovaPACSNovarad Corporation20165—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K182894HM70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201910—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173713HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201891
+7K173513WS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2018321
+7K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201839—
+7K172732E-CUBE 8Alpinion Medical Systems Co., Ltd.201711—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171754NovaPACSNovarad Corporation201741
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K231662Aid-UIaid20241—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K200699HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.20200—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K192903RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.202021—
+8K192505HS50/HS60 Diagnostics Ultrasound SystemSamsung Medison Co., Ltd.201910—