510(k) Report

Devices descending from K040468

255 later devices reach Cedara I-Softview and Cedara I-Readmammo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141364Climb Mammography Viewer SoftwareClimb Medical Systems, Inc.20140—
+1K081630Mammo WorkstationImage Diagnost International GmbH20084—
+1K073272Workstationone Breast Imaging WorkstationThree Palm Software, LLC200727—
+1K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+2K132188Mammography Viewer SMV658Fujifilm Medical System U.S.A., Inc.20130—
+2K123575MammoworkstationImage Diagnost International GmbH20132—
+2K092954Cadstream Version 5Confirma, Inc.200983
+2K082483QuantraHologic, Inc.200825—
+2K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+2K071241LMS-LiverMedian Technologies20079—
+3K231130TumorSight VizSimBioSys, Inc.20232—
+3K170195QuantXQuantitative Insights, Inc.20174—
+3K143361Mammo WorkstationGE Healthcare20151—
+3K132742M-VU Breast DensityVucomp, Inc.201311—
+3K121213VitreaadvancedVital Images, Inc.201281
+3K120472QuantraHologic, Inc.20123—
+3K102556Volpara, Version 1.3Matakina Technology Limited201024—
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K243189TumorSight VizSimBioSys, Inc.20241—
+4K210670BU-CADTaihao Medical, Inc.20213—
+4K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+4K180125PowerLook Density Assessment SoftwareIcad, Inc.20182—
+4K170540DM-DensityDensitas, Inc.20187—
+4K152009DENSEEMAMMO v1.0Statlife20161—
+4K160937SenolrisGE Healthcare20160—
+4K153289HealthmyneHealthmyne, Inc.20160—
+4K153427Volpara Imaging SoftwareMatakina Technology, Ltd.20163—
+4K152028Volpara Imaging SoftwareMatakina Technologies Limited20158—
+4K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+4K142037QuantraHologic, Inc.20141—
+4K130704Microdose SIPhilips Digital Mammography Sweden AB20130—
+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
+5K203785ClariSIGMAMClaripi, Inc.20210—
+5K211506PowerLook Density Assessment V4.0Icad, Inc.20210—
+5K201411Visage Breast DensityVisage Imaging GmbH20210—
+5K202700ART-PlanTherapanacea20215—
+5K200323AutoContourRadformation, Inc.20207—
+5K192973densitas densityaiDensitas, Inc.20205—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K182310Volpara Imaging SoftwareVolpara Health Technologies Limited20182—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K173574DenSeeMammoStatlife20180—
+5K172832Insight BDSiemens Medi Cal Solutions, Inc.20180—
+5K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K163623QuantraHologic, Inc.20170—
+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—
+6K232096Transpara Density 1.0.0Screenpoint Medical B.V.20230—
+6K222275Saige-DensityDeepHealth, Inc.20221—
+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—
+6K211279Volpara Imaging SoftwareVolpara Health Technologies Limited20210—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K202013WRDensity by Whiterabbit.aiWhiterabbit.Ai, Inc.20202—
+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—