510(k) Report

Devices descending from K063762

263 later devices reach Syngo Circulation Software Package with Extended Functionality through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110366Syngo.CT Cardiac FunctionSiemens AG2011251
+1K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+1K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+1K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+1K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+1K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+2K2608794DMInvia, LLC20260—
+2K240786AutoChamberHeartLung Corporation20241—
+2K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+2K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+2K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+2K132523MyoperfusionToshibamedical Systems Corporation201311
+2K130393Mirada RTXMirada Medical, Ltd.201336—
+2K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+2K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+2K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+2K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+2K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+2K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+2K102687Mirada RTMirada Medical, Ltd.201037—
+2K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+2K101228Mirada XDMirada Medical, Ltd.201070—
+2K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+3K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+3K252029AI-CVDHeartLung Corporation20250—
+3K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+3K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+3K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+3K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+3K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+3K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+3K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+3K220779XDMirada Medical, Ltd.20220—
+3K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+3K202700ART-PlanTherapanacea20215—
+3K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+3K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+3K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+3K200323AutoContourRadformation, Inc.20207—
+3K190868Cleerly LabsCleerly, Inc.20197—
+3K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+3K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+3K181572Workflow BoxMirada Medical, Ltd.201825—
+3K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+3K173542Arterys Oncology DLArterys, Inc.20185—
+3K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+3K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+3K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+3K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+3K161201ClearRead CTRiverain Technologies, LLC20165—
+3K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+3K151212Ziostation2Qi Imaging, LLC20152—
+3K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+3K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+3K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+3K133521Aze Phoenix SoftwareAze, Ltd.20140—
+3K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+3K123920Syngo.ViaSiemens AG Medical Solutions201363—
+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—
+3K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+3K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+4K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+4K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+4K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+4K242919V5med Lung AIV5med, Inc.20250—
+4K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+4K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+4K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+4K221612ClearRead CTRiverain Technologies, Inc.20220—
+4K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+4K220349TeraRecon NeuroTerarecon,Inc.20220—
+4K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+4K220813Art-PlanTherapanacea20224—
+4K212915MVision AI SegmentationMVision AI20221—
+4K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+4K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+4K210831OnQ NeuroCortechs Labs, Inc.20213—
+4K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K211655aPROMISEExini Diagnostics AB20211—
+4K211459syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.20214—
+4K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+4K202928DV. TargetDeepvoxel, Inc.20210—
+4K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+4K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+4K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+4K193252Contour ProtegeAIMim Software, Inc.20206—
+4K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+4K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+4K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+4K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+4K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+4K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+4K182034Arterys MICAArterys, Inc.20183—
+4K181892Ziostation2Ziosoft, Inc.20181—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K171303Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664University of Texas Medical School AT Houston, Texas20175—