510(k) Report

Devices descending from K973010

386 later devices reach Realtime 3D Diagnostic Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+6K163574Multi Modality ViewerVital Images, Inc.20171—
+6K160371NovaPACSNovarad Corporation20165—
+6K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K151780CAAS WorkstationPie Medical Imaging BV20169—
+6K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+6K150738VitreaViewVital Images, Inc.20158—
+6K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—
+6K143044CAAS A-ValvePie Medical Imaging BV20150—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+6K083691BonevueMicromri, Inc.20090—
+6K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+6K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+6K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+6K072821Vitrea 4DCTVital Images, Inc.2008171
+7K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K251766TumorSight VizSimBioSys, Inc.20250—
+7K240036PIUR tUS InfinityPiur Imaging GmbH20241—
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K211655aPROMISEExini Diagnostics AB20211—
+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—
+7K190868Cleerly LabsCleerly, Inc.20197—
+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—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K181336HS50 / HS60 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201831—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K181617E-CUBE 8Alpinion Medical Systems Co., Ltd.20180—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+7K182230Multi Modality ViewerVital Images, Inc.20180—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+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—
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K172129HS40 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.201735—
+7K171754NovaPACSNovarad Corporation201741
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K141329RadspaTelerad Tech Private Limited20140—
+7K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+7K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+7K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K250484PIUR tUS insidePiur Imaging GmbH20250—
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K231662Aid-UIaid20241—
+8K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—