510(k) Report

Devices descending from K000315

450 later devices reach Ventricular Analysis Toolkit Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+7K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K121213VitreaadvancedVital Images, Inc.201281
+7K121023Spectrum V.0Intrinsic Medical Imaging20120—
+7K120207VISIAMeVis Medical Solutions AG20120—
+7K120484Visia OncologyMeVis Medical Solutions AG20128—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+7K092954Cadstream Version 5Confirma, Inc.200983
+7K083691BonevueMicromri, Inc.20090—
+7K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+7K082607Mri-Plaque View, Version 1.1.2003Vpdiagnostics, Inc.20080—
+7K073156Qplaque MRMedis Medical Imaging Systems BV200821—
+7K072821Vitrea 4DCTVital Images, Inc.2008171
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K260166Bunkerhill Contrast CACBunkerHill Health20260—
+8K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+8K250662Bunkerhill MACBunkerHill Health20250—
+8K243859PRAEVAorta®2Nurea20250—
+8K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+8K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+8K243229Bunkerhill AVCBunkerHill Health20253—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+8K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231683inHEART ModelsInheart, Sas20240—
+8K231130TumorSight VizSimBioSys, Inc.20232—
+8K223261Open RibCanon Medical Informatics, Inc.20230—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+8K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K220813Art-PlanTherapanacea20224—
+8K212915MVision AI SegmentationMVision AI20221—
+8K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K210670BU-CADTaihao Medical, Inc.20213—
+8K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K211655aPROMISEExini Diagnostics AB20211—
+8K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+8K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K193252Contour ProtegeAIMim Software, Inc.20206—
+8K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+8K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+8K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+8K183012vascuCAPElucid Bioimaging, Inc.20182—
+8K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+8K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+8K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+8K163232Vitrea ViewVital Images, Inc.20177—
+8K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+8K153289HealthmyneHealthmyne, Inc.20160—
+8K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+8K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+8K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+8K132853NovapacsNovarad Corp.201462
+8K141329RadspaTelerad Tech Private Limited20140—
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K083084CT Brain Perfusion for ZiostationZiosoft, Inc.20080—
+9K260086CadAI-B DxBeamWorks, Inc.20260—
+9K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+9K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+9K243189TumorSight VizSimBioSys, Inc.20241—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+9K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+9K240620Cube NavigatorMedical Templates AG20240—
+9K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+9K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+9K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+9K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+9K223424Spine Auto ViewsGE Medical Systems SCS20230—