510(k) Report

Devices descending from K041484

222 later devices reach Undecided through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+2K092954Cadstream Version 5Confirma, Inc.200983
+2K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+2K071241LMS-LiverMedian Technologies20079—
+3K231130TumorSight VizSimBioSys, Inc.20232—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K243189TumorSight VizSimBioSys, Inc.20241—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K130393Mirada RTXMirada Medical, Ltd.201336—
+4K102687Mirada RTMirada Medical, Ltd.201037—
+4K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+4K101228Mirada XDMirada Medical, Ltd.201070—
+4K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K251766TumorSight VizSimBioSys, Inc.20250—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K220779XDMirada Medical, Ltd.20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K113620Myrian 1.11Intrasense20126—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K220813Art-PlanTherapanacea20224—
+6K212915MVision AI SegmentationMVision AI20221—
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212896Visible Patient SuiteVisible Patient, Sas20213—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K233457RUSHutom, Inc.20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230023ART-PlanTherapanacea Sas20233—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K210632Contour ProtegeAIMim Software, Inc.20215—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—