510(k) Report

Devices descending from K010336

494 later devices reach Advantage Windows CT/Pet Fusion through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100881Synapse Obliquus Mip/MPR/FusionFujifilm Medical System U.S.A., Inc.20101—
+1K093234Integrated RegistrationGE Medical Systems SCS20090—
+1K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+1K070248VelocityaisVelocity Medical Solutions, LLC200765—
+1K061370Cardiq FusionGE Healthcare200651—
+1K052345Advantage Sim MDGE Healthcare2005213
+1K041484UndecidedSiemens Medical Solutions USA, Inc.2004222—
+1K022310Advantage Windows X-Ray/MR FusionGe Medical Systems, Inc.20021—
+1K020546Fusion 7DMirada Solutions, Ltd.2002442—
+2K233572AutofusePymedix20240—
+2K180522IGTFusionIgi Technologies20180—
+2K173636VelocityVarian Medical Systems, Inc.20188—
+2K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+2K153014Mobius3DMobius Medical Systems, LP201613—
+2K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+2K130393Mirada RTXMirada Medical, Ltd.201336—
+2K124048ImagequbeIntuitive Imaging Informatics, LLC20130—
+2K113543ONDEMAND3DCybermed, Inc.20119—
+2K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+2K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+2K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+2K083673Carestream Pacs, Model Carestream Pacs ViiCarestream Health, Inc.200812—
+2K080325IGROKIgrok, LLC20080—
+2K071950Syngo TruedSiemens Medical Solutions USA, Inc.2007201—
+2K061671Syngo Trued, Model VC10ASiemens Medical Solutions200611—
+2K061214Aquariusaps ServerTerarecon,Inc.2006134—
+2K060378VITREA2 Version 3.8.1Vital Images, Inc.20061—
+2K053301Cedara I-Response Cedara Pet/CTCedara Software Corp.2006221—
+2K052467Brain Viewrx Viewer, Version 1.0Kyron Clinical Imaging, Inc.20055—
+2K052305Mri Soft Tissue Motion Correction Software VA10ASiemens Medical Solutions USA, Inc.200534—
+2K041286Dynacad V1.0Mri Devices Corp.200417—
+2K040305VITREA2 Version 3.5Vital Images, Inc.2004164—
+2K031779CadstreamConfirma, Inc.200319—
+3K242810RadUnity (Version 1.0.0)Radunity Corp.20240—
+3K240786AutoChamberHeartLung Corporation20241—
+3K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+3K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+3K210719Change Healthcare Anatomical AIChange Healthcare Canada Company20210—
+3K202700ART-PlanTherapanacea20215—
+3K200323AutoContourRadformation, Inc.20207—
+3K201798myQA iONIba Dosimetry GmbH202011
+3K191959QuantX Breast MRI Biopsy Guidance PluginQlarity Imaging20190—
+3K191610RTappSegana, LLC20191—
+3K191761Mobius3DVarian Medical Systems, Inc.20195—
+3K182966PLANET Onco DoseDosisoft20191—
+3K182855ProKnow DSProknow, LLC20192—
+3K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+3K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+3K173744ProFuse CADEigen20181—
+3K181572Workflow BoxMirada Medical, Ltd.201825—
+3K171350Collision CheckRadformation, Inc.20174—
+3K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+3K151115MR Core SoftwareVital Images, Inc.20153—
+3K132853NovapacsNovarad Corp.201462
+3K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+3K133030Dynacad/Prostate Interventional (Dynaloc/Prostate)Invivo Corporation201411
+3K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc.20132—
+3K132773Sidexis 4Sirona Dental Systems GmbH20131—
+3K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+3K121916IntuitionTerarecon,Inc.201351
+3K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+3K120734Microsoft Amalga Uis Image Processing ModuleMicrosoft Corp.20120—
+3K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+3K120161Alphapoint Imaging SoftwareRadlogics, Inc.20120—
+3K110919Carestream PacsCarestream Health, Inc.2011850
+3K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+3K110256The IC-Pro SystemPaieon, Inc.201115—
+3K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+3K100094Carestream Image SuiteCarestream Heatlh, Inc.201022
+3K092954Cadstream Version 5Confirma, Inc.200983
+3K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+3K090038Syngo BrevisSiemens Medical Solutions USA, Inc.20090—
+3K090223Icad Breast Interventional Planning Software, Model D70024Icad, Inc.200901
+3K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+3K081556Cadstream, Version 5.0Confirma, Inc.20099—
+3K081792Spy Analysis Toolkit, Model SA9000Novadaq Technologies, Inc.20080—
+3K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+3K071241LMS-LiverMedian Technologies20079—
+3K063031Prism View, ModelKyron Clinical Imaging, Inc.20062—
+3K060453Aze VirtualplaceAze, Ltd.20061—
+3K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+3K041020Cadstream Version 3.1Confirma, Inc.20040—
+4K260597Virtue QAProNova Solutions20260—
+4K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+4K252029AI-CVDHeartLung Corporation20250—
+4K251363ProKnow DSElekta Solutions AB20250—
+4K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+4K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+4K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+4K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+4K240822Image Management V15Philips Medical Systems Technologies20240—
+4K231130TumorSight VizSimBioSys, Inc.20232—
+4K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+4K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+4K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+4K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+4K220813Art-PlanTherapanacea20224—
+4K212915MVision AI SegmentationMVision AI20221—
+4K212887RTappSegana, Inc.20210—
+4K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—