510(k) Report

Devices descending from K954678

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K120361Synapse 3D Base ToolsFujifilm Medical Systems U.S.A, Inc.201213—
+6K113594C-THV SystemPaieon, Inc.20120—
+6K111758Cadens (TM) ColonDog Microsystems, Inc.20120—
+6K113076Caas a-ValvePie Medical Imaging BV20121—
+6K112251Swissmeda Dental Planning SystemSwissmeda AG20124—
+6K110186Synapse 3D Liver AnalysisFujifilm Medical System U.S.A., Inc.20113—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K092013Syngo Volume Perfusion-CT BodySiemens AG Medical Solutions20096—
+6K091001Myrian 1.4Intrasense20097—
+6K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+6K082144Amicas Pacs, Version 6.0Amicas, Inc.2008313
+6K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+6K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+6K071362Vital Connect 4.1Vital Images, Inc.2007113
+6K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+6K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+7K260086CadAI-B DxBeamWorks, Inc.20260—
+7K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.20260—
+7K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+7K2503303mensio WorkstationPie Medical Imaging BV202501
+7K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+7K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+7K251168Image SuiteCarestream Health, Inc.20250—
+7K251484CT:VQ4Dmedical Limited20250—
+7K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+7K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+7K242500LaralabLaralab GmbH20250—
+7K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+7K243189TumorSight VizSimBioSys, Inc.20241—
+7K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+7K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+7K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+7K240620Cube NavigatorMedical Templates AG20240—
+7K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+7K232698NemoScanSoftware Nemotec S.L.20240—
+7K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+7K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+7K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K223261Open RibCanon Medical Informatics, Inc.20230—
+7K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+7K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+7K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K211114Will3DHdx Will Corp.20210—
+7K210241ImplaStationProdigident, Inc.20210—
+7K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+7K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+7K193301coDiagnostiXDental Wings GmbH20210—
+7K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+7K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+7K202700ART-PlanTherapanacea20215—
+7K200572Planmeca RomexisPlanmeca Oy20202—
+7K200323AutoContourRadformation, Inc.20207—
+7K2022563Shape Implant Studio3Shape Medical A/S20201—
+7K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+7K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+7K200822BraidBraid.Health20201—
+7K201296i-Rapha SolutionIrm, Inc.20200—
+7K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K193403UroNav SystemInvivo Corporation20191—
+7K192038Emprint Visualization ApplicationCovidien, LLC20191—
+7K191530StoneCheckerImaging Biometrics, LLC20191—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K190874Materialise Mimics EnlightMaterialise NV20192—
+7K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K180867AmCAD-UOAmcad Biomed Corporation20180—
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+7K181926InVivo Web ViewerAnatomage, Inc.20180—
+7K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K1808835D ViewerSamsung Medison Co., Ltd.20180—
+7K180549ZED LinkZed Technologies20180—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171385Planmeca RomexisPlanmeca Oy20171—
+7K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K1725133D EchoJointvue, LLC20171—
+7K171754NovaPACSNovarad Corporation201741
+7K163668SuitestensaEbit Srl20170—
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+7K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+7K163574Multi Modality ViewerVital Images, Inc.20171—