510(k) Report

Devices descending from K982004

274 later devices reach CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020929Smartscore 3.5; Smartscore 4.0; Smartscore 4.5GE Medical Systems2002272—
+1K013146Viatronic V3D Calcium ScoringViatronix, Inc.20011—
+2K213725CardIQ SuiteGE Medical Systems SCS20224—
+2K072737CSCS-001A Calcium Scoring PackageToshiba America Medical Systems, In.C200745—
+2K050033LucionMevisys Co., Ltd.20053—
+2K032823Medicheart, Model Release 1Medicsight20030—
+2K022919Smart Breath Respiratory Compensation OptionGE Medical Systems2002217—
+3K252217CT VScore+Canon Medical Informatics, Inc.20250—
+3K233731CardIQ SuiteGE Medical Systems SCS20242—
+3K172983HealthCCSZebra Medical Vision, Ltd.201814—
+3K083446Cardiac Function Analysis, Calcium ScoringZiosoft, Inc.200929—
+3K062164Resolutionmd, Version 1.3Calgary Scientific, Inc.20062—
+3K032915Advantage 4D OptionGe Medical Systems, LLC2003216—
+4K243672CardIQ SuiteGE Medical Systems SCS20251—
+4K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+4K192763syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20193—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K132410Discovery CT 590 RT, Optima CT 580, Optima CT 580 RT, Optima CT 580 WGe Medical Systems, LLC201402
+4K113086ACQATexas Medical Imaging Consultants20120—
+4K111373CT42 Cardiac Computed Tomography (CT) SoftwareCircle Cardiovascular Imaging, Inc.201125—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K052345Advantage Sim MDGE Healthcare2005213
+5K253770CardIQ SuiteGE Medical Systems SCS20260—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K241440HealthCCSngNano-X AI, Ltd.20240—
+5K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+5K230112CAC SoftwareImbio, Inc.20230—
+5K230223iCAC DeviceBunkerhill, Inc.20236—
+5K213998cvi42 Auto Imaging Software ApplicationCircle Cardiovascular Imaging, Inc.20227—
+5K203256Imbio RV/LV SoftwareImbio, LLC202117—
+5K201034Syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20202—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+6K260166Bunkerhill Contrast CACBunkerHill Health20260—
+6K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+6K250662Bunkerhill MACBunkerHill Health20250—
+6K243038Salix CentralArtrya Limited20251—
+6K241922MyomicsPhantomics, Inc.20250—
+6K243229Bunkerhill AVCBunkerHill Health20253—
+6K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+6K2420621CMR ProMycardium AI Limited20240—
+6K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc.20240—
+6K240786AutoChamberHeartLung Corporation20241—
+6K241847Imbio PHA (4.0.0)Imbio, Inc.20240—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K223396Rapid RV/LVIschemaview, Inc.20231—
+6K221100Viz RV/LVViz. Ai, Inc.20224—
+6K220624AI4CMR v1.0Ai4medimaging Medical Solutions S.A.20222—
+6K221219syngo.CT CaScoringSiemens Medical Solutions USA, Inc.20220—
+6K220779XDMirada Medical, Ltd.20220—
+6K212624EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment SystemEver Fortune.Ai, Co., Ltd.20223—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K202700ART-PlanTherapanacea20215—
+6K200323AutoContourRadformation, Inc.20207—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K113620Myrian 1.11Intrasense20126—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+6K071241LMS-LiverMedian Technologies20079—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+7K252084AI4CMR v2.0Ai4medimaging Medical Solutions S.A.20260—
+7K252029AI-CVDHeartLung Corporation20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K243378Rapid MLSIschemaview, Inc.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K232613CT CardiomegalyInnolitics, LLC20241—
+7K230534BriefCase-QuantificationAidoc Medical, Ltd.20233—
+7K231149qXR-CTRQure.Ai Technologies20230—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220813Art-PlanTherapanacea20224—
+7K212915MVision AI SegmentationMVision AI20221—
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—