510(k) Report

Devices descending from K980648

672 later devices reach Pro Vision through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K100793Urostation 3D Prostate SuiteKoelis20107—
+4K101662Synapse 3D Basic ToolsFujifilm Medical System U.S.A., Inc.201014—
+4K100094Carestream Image SuiteCarestream Heatlh, Inc.201022
+4K093672Aegis Navigation Anda Egis Pelvic ApplicationSentinelle Medical, Inc.20098—
+4K092954Cadstream Version 5Confirma, Inc.200983
+4K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+4K090607Blue Sky Bio Plan, Version .38Blue Sky Bio, LLC20092—
+4K081168Brit Pacs SystemsBrit Systems, Inc.20090—
+4K082964Prism Acquire (Version 1.5), Prism Process (Version 1.5), Prism View (Version 2.5)Prism Clinical Imaging, Inc.20091—
+4K090295Bodyviz, Model 100Visual Medical Solutions, LLC20090—
+4K082228Planisight LinasysPathfinder Therapeutics, Inc.200823—
+4K073526Amicas Vision Series Pacs, Model 5.5Amicas, Inc.20084—
+4K073169Scimage PicomenterpriseScimage, Inc.20080—
+4K073373Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions200733—
+4K071636Codiagnostix (R) 5.72Ivs Solutions AG2007212
+4K070803InvivodentalAnatomage, Inc.200738—
+4K061696Iqqa-Liver SoftwareEdda Technology, Inc.2006217—
+4K063031Prism View, ModelKyron Clinical Imaging, Inc.20062—
+4K063037Centarisone Ris/PacsCentarisone, LLC20060—
+4K062328Vitreaaccess, Version 1.0Vital Images, Inc.20060—
+4K062154Vital Connect 4.0Vital Images, Inc.2006124
+4K060453Aze VirtualplaceAze, Ltd.20061—
+4K043333VITREA2, Version 3.7 Medical Image Processing SystemVital Images, Inc.20041431
+5K241543DrAid™ for Liver SegmentationVinbrain Joint Stock Company20240—
+5K241223eRAD PACSErad, Inc.20240—
+5K240822Image Management V15Philips Medical Systems Technologies20240—
+5K231690iCAS-LVHighrad, Ltd.20240—
+5K231130TumorSight VizSimBioSys, Inc.20232—
+5K221499Minimally Invasive Prostate Surgery Navigation SystemAugment Intelligent Medical System (China) Co., Ltd.20221—
+5K210670BU-CADTaihao Medical, Inc.20213—
+5K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+5K211655aPROMISEExini Diagnostics AB20211—
+5K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+5K200750Neuro.Al AlgorithmTerarecon,Inc.20201—
+5K200274CariCloudCaristo Diagnostics20200—
+5K193369Xelis Dental 2.0Infinitt Healthcare Co., Ltd.20200—
+5K191585iNtuition-Structural Heart ModuleTerarecon,Inc.20192—
+5K190096R2GATEMegagen Implant Co., Ltd.20191—
+5K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+5K183133MRCP+ v1.0Perspectum Diagnostics, Ltd.20191—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K181247Vitrea CT Brain PerfusionVital Images, Inc.20180—
+5K182561UroNav (Version 3.0)Invivo Corporation20182—
+5K181290Fusion Bx 2.0Focal Healthcare, Inc.20180—
+5K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+5K180192Emprint Ablation Visualization ApplicationCovidien, LLC20182—
+5K173054Navigo Workstation Version 2.0UC-CARE, Ltd.20181—
+5K170841BiopSee, Mobile USMedcom GmbH20170—
+5K170250SmartTargetSmarttarget, Ltd.201701
+5K170180Will3DHdx Will Corp.20171—
+5K161341Lifesys PacsLifetrack Medical Systems, Inc.20170—
+5K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+5K160934UC-CARE NaviGo WorkstationUC-CARE, Ltd.20172—
+5K160371NovaPACSNovarad Corporation20165—
+5K1619555D ViewerSamsung Medison Co., Ltd.20163—
+5K161419Multi Modality ViewerVital Images, Inc.20162—
+5K161061IMPAX Volume Viewing 4.0Agfa Healthcare N.V.20160—
+5K1537363mensio WorkstationPie Medical Imaging BV2016191
+5K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+5K152977DG PacsDicom Grid, Inc.201641
+5K153289HealthmyneHealthmyne, Inc.20160—
+5K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+5K151283Lung Analysis SoftwareVital Images, Inc.20158—
+5K151957BOX DICOM ViewerBox, Inc.20153—
+5K151371Corporate Dental Imaging (CDI) ApplicationU.S. Army Dental Command (Dencom)20150—
+5K142521Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20145—
+5K133643Syngo, CT Liver AnalysisSiemens Medi Cal Solutions, Inc.20141—
+5K141745Iqqa-Bodyimaging SoftwareEdda Technology20146—
+5K141302Vitrea CT Multi-Chamber Cardiac Functional Analysis (Cfa)Vital Images, Inc.20142—
+5K141475EndosizeTherenva Sas201416—
+5K133521Aze Phoenix SoftwareAze, Ltd.20140—
+5K140271Tablet Viewer Software for Image SuiteCarestream Health, Inc.20141—
+5K133993Caas WorkstationPie Medical Imaging201410—
+5K132824Carestream Vue Pacs Version 11.4 Carestream Vue Motion ApplicationCarestream Health, Inc.20146—
+5K132773Sidexis 4Sirona Dental Systems GmbH20131—
+5K130242Maven ProNsequence20130—
+5K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+5K1314483D Prostate Suite 3DTRUS Prostate Mapping, Mri/3DTRUS Fusion Option, Second Look 3DTRUS…Koelis20136—
+5K130724Codiagnostix Implant Planning SoftwareStraumann USA201315—
+5K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+5K130393Mirada RTXMirada Medical, Ltd.201336—
+5K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+5K122578Vitrea CT Transcatheter Aortic Valve Replacment (Tavr) PlanningVital Images, Inc.20135—
+5K123519Invivo DentalAnatomage, Inc.201324—
+5K123901Tractus Tissuemapper Reviewer ApplicationTractus Corporation20132—
+5K123920Syngo.ViaSiemens AG Medical Solutions201363—
+5K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+5K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+5K120282CardnavPaieon, Inc.20120—
+5K122026Prism Acquire Prism Process Prism ViewPrism Clinical Imaging, Inc.20120—
+5K113620Myrian 1.11Intrasense20126—
+5K120187Multi-Modality Image FusionIgt, LLC Dba Eigen20124—
+5K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+5K113594C-THV SystemPaieon, Inc.20120—
+5K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+5K113076Caas a-ValvePie Medical Imaging BV20121—
+5K112251Swissmeda Dental Planning SystemSwissmeda AG20124—
+5K110186Synapse 3D Liver AnalysisFujifilm Medical System U.S.A., Inc.20113—
+5K101749Syngo Trued SoftwareSiemens Medical Solutions201076—