510(k) Report

Devices descending from K963345

472 later devices reach Advantage Windows Tissue Volume Option through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101279CORRIDOR4DM V2010 Model: V2010Invia201012—
+4K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K100637Syngo.CT Coronary AnalysisSiemens AG Medical Solutions20102—
+4K100236Stair Systems Pacs & Dicom ViewerStair Systems, Inc.20101—
+4K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K083327Syngocirculation Dynamicpet, Version 1.0Siemens Medical Solutions USA, Inc.200920—
+4K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+4K062154Vital Connect 4.0Vital Images, Inc.2006124
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+4K042408Iqqa-Chest Software PackageEdda Technology, Inc.20040—
+4K041484UndecidedSiemens Medical Solutions USA, Inc.2004222—
+4K041380Imagechecker-CT Software Package with Filling Defect IndicatorR2 Technology, Inc.20043—
+5K2608794DMInvia, LLC20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K251883MIM – LesionID ProMim Software, Inc.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K240786AutoChamberHeartLung Corporation20241—
+5K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+5K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K212889Syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20223—
+5K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K202084DeepLook PRECISEDeeplook, Inc.20210—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K200274CariCloudCaristo Diagnostics20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K192065Syngo.Via RT Image SuiteSiemens Medical Solutions USA, Inc.201962
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K183037Monaco RTP SystemElekta, Inc.201856
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173512MFI-CardiacMultifunctional Imaging, LLC20180—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K160371NovaPACSNovarad Corporation20165—
+5K161419Multi Modality ViewerVital Images, Inc.20162—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142434Artiste Solution, Sys_VC10C, Phase 2 Update with the Syngo RT Therapist & RT Oncologist…Siemens Medical Solutions USA, Inc.201415
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+5K132523MyoperfusionToshibamedical Systems Corporation201311
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+5K120282CardnavPaieon, Inc.20120—
+5K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+5K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+5K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+5K112008Touchpacs SuiteTouch Medical Solutions, Inc.20120—
+5K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+5K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+5K102687Mirada RTMirada Medical, Ltd.201037—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+5K101228Mirada XDMirada Medical, Ltd.201070—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+5K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+5K071362Vital Connect 4.1Vital Images, Inc.2007113
+5K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+5K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K232155syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20232—
+6K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K220349TeraRecon NeuroTerarecon,Inc.20220—
+6K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K220779XDMirada Medical, Ltd.20220—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K202990NinesMeasureNines, Inc.20211—
+6K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+6K202700ART-PlanTherapanacea20215—
+6K201250SQuEEZ SoftwareCardiowise, Inc.20200—