510(k) Report

Devices descending from K011142

211 later devices reach Aquarius Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+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—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K092954Cadstream Version 5Confirma, Inc.200983
+6K091498Vitrea Endovascular Stent Planning SoftwareVital Images, Inc.200911
+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—
+7K252029AI-CVDHeartLung Corporation20250—
+7K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+7K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+7K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+7K210670BU-CADTaihao Medical, Inc.20213—
+7K190868Cleerly LabsCleerly, Inc.20197—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K182230Multi Modality ViewerVital Images, Inc.20180—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K180019CAAS WorkstationPie Medical Imaging BV20188—
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K143079Endovascular Stent Planning SoftwareVital Images, Inc.20140—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K132853NovapacsNovarad Corp.201462
+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—
+8K260086CadAI-B DxBeamWorks, Inc.20260—
+8K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+8K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+8K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+8K251355X1-FFRSpectrawave, Inc.20250—
+8K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+8K232147CAAS WorkstationPie Medical Imaging BV20241—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+8K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+8K221463ElucidVivo A.3Elucid Bioimaging, Inc.20221—
+8K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+8K200315Ziostation2Ziosoft, Inc.20200—
+8K191530StoneCheckerImaging Biometrics, LLC20191—
+8K182611Qangio XA 3DMedis Medical Imaging Systems BV20194—
+8K190764SurgicalARMedivis, Inc.20196—
+8K180867AmCAD-UOAmcad Biomed Corporation20180—
+8K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+8K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+8K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+8K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+8K160371NovaPACSNovarad Corporation20165—
+8K151988Visible Patient SuiteVisible Patient, Sas20154—
+8K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K251766TumorSight VizSimBioSys, Inc.20250—
+9K244012Mosaic (V1.0.1)Navier Medical20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K243769QFR (3.0)Qfr Solutions BV20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+9K230249IkshanaImmersivetouch20231—
+9K221870CarnaLife HoloMedapp S.A.20230—
+9K213215VSI HoloMedicineApoqlar GmbH20222—
+9K212896Visible Patient SuiteVisible Patient, Sas20213—
+9K210093AccuFFRangioArteryFlow Technology Co., Ltd.20212—
+9K202084DeepLook PRECISEDeeplook, Inc.20210—
+9K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+9K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+9K171754NovaPACSNovarad Corporation201741
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K253486SKIA-Head (Model: SKIA-ST00)Skia, Inc.20260—
+10K251577Laia XRAugmented Reality Software S.L.20260—
+10K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+10K240094LumiNE US; LumiAugmedit B.V.20240—
+10K233457RUSHutom, Inc.20240—
+10K231662Aid-UIaid20241—
+10K230303AccuFFRangio PlusArteryFlow Technology Co., Ltd.20230—
+10K221711AccuICASArteryFlow Technology Co., Ltd.20230—
+10K221796Cyware 4H and Cysart 4HAbys Medical20221—
+10K220039AutoSegAi Medic, Inc.20221—
+10K220727inHEART MODELSInheart, Sas20221—
+10K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+11K260973InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—