510(k) Report

Devices descending from K052029

296 later devices reach Syngo Circulation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073003Syngo Dual Energy with Extended FunctionallySiemens Medi Cal Solutions, Inc.2008168—
+1K063762Syngo Circulation Software Package with Extended FunctionalitySiemens AG Medical Solutions2007263—
+2K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+2K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+2K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+2K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+2K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+2K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+3K2608794DMInvia, LLC20260—
+3K240786AutoChamberHeartLung Corporation20241—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+3K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+3K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+3K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+3K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K132523MyoperfusionToshibamedical Systems Corporation201311
+3K130393Mirada RTXMirada Medical, Ltd.201336—
+3K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+3K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+3K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+3K113620Myrian 1.11Intrasense20126—
+3K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+3K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+3K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+3K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+3K102687Mirada RTMirada Medical, Ltd.201037—
+3K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+3K101228Mirada XDMirada Medical, Ltd.201070—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K242919V5med Lung AIV5med, Inc.20250—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K220779XDMirada Medical, Ltd.20220—
+4K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K202700ART-PlanTherapanacea20215—
+4K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+4K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+4K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+4K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+4K200323AutoContourRadformation, Inc.20207—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+4K200315Ziostation2Ziosoft, Inc.20200—
+4K190868Cleerly LabsCleerly, Inc.20197—
+4K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+4K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+4K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K173542Arterys Oncology DLArterys, Inc.20185—
+4K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+4K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+4K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+4K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+4K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+4K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+4K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—