510(k) Report

Devices descending from K041267

331 later devices reach Cardiq Analysis Iii through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+5K202700ART-PlanTherapanacea20215—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+5K200323AutoContourRadformation, Inc.20207—
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+5K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+5K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K261210Cleerly PlaqueCleerly, Inc.20260—
+6K260588Cleerly LABSCleerly, Inc.20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+6K241440HealthCCSngNano-X AI, Ltd.20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+6K223261Open RibCanon Medical Informatics, Inc.20230—
+6K230112CAC SoftwareImbio, Inc.20230—
+6K230223iCAC DeviceBunkerhill, Inc.20236—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220813Art-PlanTherapanacea20224—
+6K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+6K220727inHEART MODELSInheart, Sas20221—
+6K212915MVision AI SegmentationMVision AI20221—
+6K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+6K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+6K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+6K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—
+6K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K260166Bunkerhill Contrast CACBunkerHill Health20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K250662Bunkerhill MACBunkerHill Health20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K243229Bunkerhill AVCBunkerHill Health20253—
+7K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+7K231683inHEART ModelsInheart, Sas20240—
+7K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+7K232000syngo.via MI Workflows; Scenium; syngo MBFSiemens Medical Solutions USA, Inc.20233—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K223424Spine Auto ViewsGE Medical Systems SCS20230—