510(k) Report

Devices descending from K000315

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+6K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+6K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K202990NinesMeasureNines, Inc.20211—
+6K201501VeolityMeVis Medical Solutions AG20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+6K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+6K172646XIDF-AWS801, Angio Workstation, V7.0Toshibamedical Systems Corporation20173—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+6K113620Myrian 1.11Intrasense20126—
+6K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+6K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K091001Myrian 1.4Intrasense20097—
+6K081556Cadstream, Version 5.0Confirma, Inc.20099—
+6K072242Cor Analyzer II, Model V1.7Rcadia Medical Imaging, Ltd.20075—
+6K071362Vital Connect 4.1Vital Images, Inc.2007113
+6K071331Vitrea Version 4.0Vital Images, Inc.2007821
+6K071000MyrianIntrasense20078—
+6K063548Cor Analyzer 1, Version 1.4Rcadia Medical Imaging, Ltd.20076—
+6K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K243378Rapid MLSIschemaview, Inc.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K241440HealthCCSngNano-X AI, Ltd.20240—
+7K232613CT CardiomegalyInnolitics, LLC20241—
+7K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+7K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+7K231149qXR-CTRQure.Ai Technologies20230—
+7K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+7K230112CAC SoftwareImbio, Inc.20230—
+7K230223iCAC DeviceBunkerhill, Inc.20236—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220039AutoSegAi Medic, Inc.20221—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K220727inHEART MODELSInheart, Sas20221—
+7K220779XDMirada Medical, Ltd.20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202700ART-PlanTherapanacea20215—
+7K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+7K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+7K200323AutoContourRadformation, Inc.20207—
+7K201710A View LCSCoreline Soft Co., Ltd.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K181415XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0Canon Medical Systems Corporation20182—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K163071vascuCAPElucid Bioimaging, Inc.20173—
+7K170195QuantXQuantitative Insights, Inc.20174—
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K143586FACT Medical Imaging SysytemDexin Medical Imaging Technology Co., Ltd.20150—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+7K150738VitreaViewVital Images, Inc.20158—
+7K150258Vitrea, Version 7.0 Medical Image Processing SoftwareVital Images, Inc.201515—