510(k) Report

Devices descending from K992654

670 later devices reach Plug 'N View 3D, Version 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K091001Myrian 1.4Intrasense20097—
+4K090504CSBP-001A Body Perfusion SystemToshibamedical Systems Corporation200910—
+4K082144Amicas Pacs, Version 6.0Amicas, Inc.2008313
+4K081482CSBP-001A Body Organ Perfusion SystemToshiba America Medical Systems, In.C20080—
+4K071310Syngo CT Oncology Software PackageSiemens AG2007195—
+4K071362Vital Connect 4.1Vital Images, Inc.2007113
+4K052632VITREA2 Version 3.8 Medical Image Processing SoftwareVital Images, Inc.20051172
+4K052963Mediq Version 1.0Clario Medical Imaging, Inc.200511—
+5K260086CadAI-B DxBeamWorks, Inc.20260—
+5K260303See-Mode Augmented Reporting Tool, Breast (SMART-B)See-Mode Technologies Pty, Ltd.20260—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K260324Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) PlanningCanon Medical Informatics, Inc.20260—
+5K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+5K2503303mensio WorkstationPie Medical Imaging BV202501
+5K250337AiORTA - PlanViTAA Medical Solutions, Inc.20251—
+5K242314Minimally Invasive Prostate Surgery Navigation System (Model:AmaKris SR1-A-2)Augment Intelligent Medical System (China) Co., Ltd.20250—
+5K251168Image SuiteCarestream Health, Inc.20250—
+5K251484CT:VQ4Dmedical Limited20250—
+5K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+5K250664Navigo Workstation 2.3 (FPRMC00039)UC-CARE, Ltd.20250—
+5K242500LaralabLaralab GmbH20250—
+5K241984Hi-D Imaging 4TAVRHi-D Imaging AG20251—
+5K243189TumorSight VizSimBioSys, Inc.20241—
+5K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)See-Mode Technologies Pte, Ltd.20240—
+5K241133Magnifico Open (100009900); Magnifico MSK ( 100009910)Esaote, S.p.A.20241—
+5K241038Cardiac CT Function Software ApplicationCircle Cardiovascular Imaging20241—
+5K240620Cube NavigatorMedical Templates AG20240—
+5K233930MRCP+ version 2 (MRCP+ v2)Perspectum20240—
+5K232698NemoScanSoftware Nemotec S.L.20240—
+5K231324DASI Dimensions (V1.0)Dasi Simulations20240—
+5K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+5K223909R2GATE Lite TMMegagen Implant Co., Ltd.20230—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K223261Open RibCanon Medical Informatics, Inc.20230—
+5K223855FEops HEARTguideTM, FEops HEARTguideTM ALPACAFeops NV20230—
+5K222593TruPlan Computed Tomography (CT) Imaging SoftwareCircle Cardiovascular Imaging, Inc.20232—
+5K222662Vitrea CT Cardiac AnalysisCanon Medical Informatics, Inc.20220—
+5K220349TeraRecon NeuroTerarecon,Inc.20220—
+5K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+5K211114Will3DHdx Will Corp.20210—
+5K210241ImplaStationProdigident, Inc.20210—
+5K212442Cydar EV (Series B) and Cydar EV MapsCydar, Ltd.20211—
+5K203411syngo.CT Skull UnfoldingSiemens Medical Solutions USA, Inc.20210—
+5K193301coDiagnostiXDental Wings GmbH20210—
+5K202212TruPlanCircle Cardiovascular Imaging, Inc.20213—
+5K203103Synapse 3D, Synapse 3D Base Tools v6.1Fujifilm Corporation20215—
+5K202700ART-PlanTherapanacea20215—
+5K200572Planmeca RomexisPlanmeca Oy20202—
+5K200323AutoContourRadformation, Inc.20207—
+5K2022563Shape Implant Studio3Shape Medical A/S20201—
+5K202335Ambra ProViewerDicom Grid Inc Dba Ambra Health202021
+5K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+5K200822BraidBraid.Health20201—
+5K201296i-Rapha SolutionIrm, Inc.20200—
+5K193267Al-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20203—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K193403UroNav SystemInvivo Corporation20191—
+5K192038Emprint Visualization ApplicationCovidien, LLC20191—
+5K191530StoneCheckerImaging Biometrics, LLC20191—
+5K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+5K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+5K190874Materialise Mimics EnlightMaterialise NV20192—
+5K183204Bone VCAR (BVCAR)GE Medical Systems SCS20191—
+5K190232Synapse PACSFujifilm Corporation2019311
+5K180867AmCAD-UOAmcad Biomed Corporation20180—
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K181892Ziostation2Ziosoft, Inc.20181—
+5K181773Synapse 3D Optional ToolsFujifilm Corporation20180—
+5K181926InVivo Web ViewerAnatomage, Inc.20180—
+5K171977miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP ViewerHinacom Software and Technology, Ltd.20180—
+5K181572Workflow BoxMirada Medical, Ltd.201825—
+5K1808835D ViewerSamsung Medison Co., Ltd.20180—
+5K180549ZED LinkZed Technologies20180—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173625syngo.CT Clinical ExtensionsSiemens Medical Solutions USA, Inc.20185—
+5K173542Arterys Oncology DLArterys, Inc.20185—
+5K173475Merge PACSMerge Healthcare Incorporated201712
+5K171385Planmeca RomexisPlanmeca Oy20171—
+5K171709BR-FHUS Viewer 1.0Taihao Medical, Inc.20171—
+5K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+5K1725133D EchoJointvue, LLC20171—
+5K171754NovaPACSNovarad Corporation201741
+5K163668SuitestensaEbit Srl20170—
+5K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+5K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+5K162287Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.20170—
+5K162484Lung Nodule Assessment and Comparison Option (LNA)Philips Medical Systems Nederland B.V.20177—
+5K163574Multi Modality ViewerVital Images, Inc.20171—
+5K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+5K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+5K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+5K161201ClearRead CTRiverain Technologies, LLC20165—
+5K160357TrinityKoelis20161—
+5K160376EndoSizeTherenva Sas201613—
+5K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+5K151780CAAS WorkstationPie Medical Imaging BV20169—
+5K151152ImplantMax SoftwareSaturn Imaging, Inc.20160—