510(k) Report

Devices descending from K020796

377 later devices reach Card IQ Analysis II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K160371NovaPACSNovarad Corporation20165—
+5K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+5K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+5K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+5K113620Myrian 1.11Intrasense20126—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+5K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+6K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+6K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+6K244012Mosaic (V1.0.1)Navier Medical20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+6K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K220779XDMirada Medical, Ltd.20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K202700ART-PlanTherapanacea20215—
+6K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+6K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+6K200323AutoContourRadformation, Inc.20207—
+6K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+6K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K171754NovaPACSNovarad Corporation201741
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+6K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+6K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+6K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+7K261210Cleerly PlaqueCleerly, Inc.20260—
+7K260588Cleerly LABSCleerly, Inc.20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K233457RUSHutom, Inc.20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231662Aid-UIaid20241—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220039AutoSegAi Medic, Inc.20221—
+7K220813Art-PlanTherapanacea20224—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K220727inHEART MODELSInheart, Sas20221—
+7K212915MVision AI SegmentationMVision AI20221—