510(k) Report

Devices descending from K020546

442 later devices reach Fusion 7D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K181572Workflow BoxMirada Medical, Ltd.201825—
+4K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+4K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+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—
+4K171754NovaPACSNovarad Corporation201741
+4K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+4K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+4K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+4K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+4K163574Multi Modality ViewerVital Images, Inc.20171—
+4K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+4K161201ClearRead CTRiverain Technologies, LLC20165—
+4K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+4K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+4K151780CAAS WorkstationPie Medical Imaging BV20169—
+4K151212Ziostation2Qi Imaging, LLC20152—
+4K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+4K151988Visible Patient SuiteVisible Patient, Sas20154—
+4K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+4K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+4K150843syngo®.via (version VB10A)Siemens AG201546—
+4K143044CAAS A-ValvePie Medical Imaging BV20150—
+4K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+4K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+4K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K121213VitreaadvancedVital Images, Inc.201281
+4K113620Myrian 1.11Intrasense20126—
+4K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+4K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+4K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+4K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K240740qCT LN QuantQure.Ai Technologies20240—
+5K231662Aid-UIaid20241—
+5K223424Spine Auto ViewsGE Medical Systems SCS20230—
+5K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+5K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K220813Art-PlanTherapanacea20224—
+5K212915MVision AI SegmentationMVision AI20221—
+5K213944HealthOSTNanoxai, Ltd.20221—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212896Visible Patient SuiteVisible Patient, Sas20213—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K202990NinesMeasureNines, Inc.20211—
+5K201501VeolityMeVis Medical Solutions AG20210—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+5K193220Aview LCSCoreline Soft Co., Ltd.20201—
+5K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+5K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+5K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+5K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K182034Arterys MICAArterys, Inc.20183—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+5K182230Multi Modality ViewerVital Images, Inc.20180—
+5K180019CAAS WorkstationPie Medical Imaging BV20188—
+5K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+5K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+5K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—