510(k) Report

Devices descending from K013422

449 later devices reach Cardiq Function through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K131424Miplatform Medical Imaging SuiteHinacom Software and Technology, Ltd.20131—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K121213VitreaadvancedVital Images, Inc.201281
+6K121023Spectrum V.0Intrinsic Medical Imaging20120—
+6K120207VISIAMeVis Medical Solutions AG20120—
+6K120484Visia OncologyMeVis Medical Solutions AG20128—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K110071Cor AnalyzerRcadia Medical Imaging, Ltd.20114—
+6K092954Cadstream Version 5Confirma, Inc.200983
+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
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K243859PRAEVAorta®2Nurea20250—
+7K243779Bunkerhill Abdominal Aortic Quantification (AAQ)BunkerHill Health20250—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K241112BriefCase-QuantificationAidoc Medical, Ltd.20241—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231683inHEART ModelsInheart, Sas20240—
+7K231130TumorSight VizSimBioSys, Inc.20232—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+7K220342XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3Canon Medical Systems Corporation20221—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K210670BU-CADTaihao Medical, Inc.20213—
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K193252Contour ProtegeAIMim Software, Inc.20206—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K183012vascuCAPElucid Bioimaging, Inc.20182—
+7K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K182034Arterys MICAArterys, Inc.20183—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+7K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+7K172855Vitrea Advanced Visualization, Version 7.6Vital Images, Inc.20170—
+7K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+7K163232Vitrea ViewVital Images, Inc.20177—
+7K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+7K153289HealthmyneHealthmyne, Inc.20160—
+7K151091Vitrea Software Toshiba Package, VSTP-001AToshibamedical Systems Corporation201513—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+7K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+7K132853NovapacsNovarad Corp.201462
+7K141329RadspaTelerad Tech Private Limited20140—
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+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—
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K242203BriefCase-QuantificationAidoc Medical, Ltd.20240—
+8K243189TumorSight VizSimBioSys, Inc.20241—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K240620Cube NavigatorMedical Templates AG20240—
+8K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+8K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+8K232526XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5Canon Medical Systems Corporation20230—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K230023ART-PlanTherapanacea Sas20233—