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
+5K152078Implant Studio 20153Shape Medical A/S20157—
+5K151212Ziostation2Qi Imaging, LLC20152—
+5K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+5K151988Visible Patient SuiteVisible Patient, Sas20154—
+5K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+5K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+5K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K150738VitreaViewVital Images, Inc.20158—
+5K143044CAAS A-ValvePie Medical Imaging BV20150—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K141570Implant Studio3Shape Medical A/S20148—
+5K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+5K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+5K140713Planmeca RomexisPlanmeca Oy201414—
+5K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+5K140093TABLEAnatomage, Inc.20144—
+5K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+5K123976NobelclinicianNobel Biocare AB20133—
+5K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+5K120484Visia OncologyMeVis Medical Solutions AG20128—
+5K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+5K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+5K113541Clearstart SVM SystemIntio, Inc.201171
+5K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+5K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+5K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+5K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+5K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+5K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+5K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+6K253902RealGUIDE3DIEMME SRL20260—
+6K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+6K260300WatchMate SoftwareAnumana, Inc.20260—
+6K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K260716NeowiseCefla S.C.20260—
+6K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+6K252195ARTICOR plannerArtiness S.R.L20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+6K252500CARA SystemCara Medical, Ltd.20260—
+6K251514Overjet CBCT AssistOverjet, Inc.20250—
+6K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+6K251766TumorSight VizSimBioSys, Inc.20250—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K250800UroNav 4Philips DS North America, LLC20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K242166TribusConnectTribusmed Beheer BV20250—
+6K242919V5med Lung AIV5med, Inc.20250—
+6K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+6K240740qCT LN QuantQure.Ai Technologies20240—
+6K233217Mimics Cardiac PlannerMaterialise NV20240—
+6K231662Aid-UIaid20241—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K223424Spine Auto ViewsGE Medical Systems SCS20230—
+6K231360Ambra PACSDicom Grid Dba Ambra Health202301
+6K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+6K230012Atomica PlannerAtomica Technology, Inc.20230—
+6K221796Cyware 4H and Cysart 4HAbys Medical20221—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+6K222070EndoNautTherenva Sas20221—
+6K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K220039AutoSegAi Medic, Inc.20221—
+6K220813Art-PlanTherapanacea20224—
+6K220727inHEART MODELSInheart, Sas20221—
+6K212915MVision AI SegmentationMVision AI20221—
+6K213944HealthOSTNanoxai, Ltd.20221—
+6K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+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—
+6K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+6K2116563D Echo v1.1Jointvue, LLC20210—
+6K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202084DeepLook PRECISEDeeplook, Inc.20210—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K202990NinesMeasureNines, Inc.20211—
+6K201501VeolityMeVis Medical Solutions AG20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K193252Contour ProtegeAIMim Software, Inc.20206—
+6K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+6K193220Aview LCSCoreline Soft Co., Ltd.20201—
+6K200315Ziostation2Ziosoft, Inc.20200—
+6K200078VARO Plan3D Industrial Imaging Co., Ltd.20200—
+6K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+6K192165Acteon Imaging SuiteDe Gotzen S.R.L.20200—
+6K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+6K192455Merge PACSMerge Healthcare Incorporated201904