510(k) Report

Devices descending from K954678

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K161109iSR'obot MRI-US FusionBiobot Surgical Pte., Ltd.20162—
+7K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K160357TrinityKoelis20161—
+7K160376EndoSizeTherenva Sas201613—
+7K160150Vitrea CT Colon AnalysisVital Images, Inc.20160—
+7K151780CAAS WorkstationPie Medical Imaging BV20169—
+7K151152ImplantMax SoftwareSaturn Imaging, Inc.20160—
+7K152078Implant Studio 20153Shape Medical A/S20157—
+7K151212Ziostation2Qi Imaging, LLC20152—
+7K150713syngo.CT Myocardial PerfusionSiemens Medical Solutions USA, Inc.20151—
+7K151988Visible Patient SuiteVisible Patient, Sas20154—
+7K151774CARESTREAM Vue MotionCarestream Health, Inc.201541
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K150738VitreaViewVital Images, Inc.20158—
+7K143044CAAS A-ValvePie Medical Imaging BV20150—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K141570Implant Studio3Shape Medical A/S20148—
+7K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+7K141514Synapse 3D Tensor AnalysisFujifilm Meidcal Systems U.S.A.,Inc.20140—
+7K140713Planmeca RomexisPlanmeca Oy201414—
+7K132524CT Transcatheter Aortic Valve Implantation (Tavi) Planning ApplicationPhilips Medical Systems201401
+7K140093TABLEAnatomage, Inc.20144—
+7K140033TARGET3D FusionConvergent Life Sciences, Inc.20140—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K123976NobelclinicianNobel Biocare AB20133—
+7K120331Syngo CT Dynamic AngioSiemens AG Medical Solutions20120—
+7K120484Visia OncologyMeVis Medical Solutions AG20128—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113541Clearstart SVM SystemIntio, Inc.201171
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies)20119—
+7K101119Syngo Dosimetrist Workspace V2.7 Model: 1056864Siemens Medical Solutions USA, Inc.2010181
+7K083524Syngo Dual Energy with Extended FunationallySiemens Medical Solutions USA, Inc.2009117—
+7K082693Resolutionmd, Release 2.1Calgary Scientific, Inc.20091—
+7K080196Z3D Contrast AcuityClario Medical Imaging, Inc.200810—
+7K071086Resolutionmd Cardiac Product Family, Model: Release 1.0Calgary Scientific, Inc.20070—
+7K061624Vitrea, Version 3.9Vital Images, Inc.20061111
+8K253902RealGUIDE3DIEMME SRL20260—
+8K261535Hi-D Imaging 4TAVRHi-D Imaging AG20260—
+8K260300WatchMate SoftwareAnumana, Inc.20260—
+8K252947HistoSonics® Planning ToolHistoSonics, Inc.20260—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K260716NeowiseCefla S.C.20260—
+8K254207AiORTA - Plan v2.0ViTAA Medical Solutions, Inc.20260—
+8K252195ARTICOR plannerArtiness S.R.L20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K251901Magnifico Open (100009900)Esaote, S.p.A.20260—
+8K252500CARA SystemCara Medical, Ltd.20260—
+8K251514Overjet CBCT AssistOverjet, Inc.20250—
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K251766TumorSight VizSimBioSys, Inc.20250—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K250800UroNav 4Philips DS North America, LLC20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K242166TribusConnectTribusmed Beheer BV20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K242781cvi42 Software ApplicationCircle Cardiovascular Imaging, Inc.20240—
+8K240740qCT LN QuantQure.Ai Technologies20240—
+8K233217Mimics Cardiac PlannerMaterialise NV20240—
+8K231662Aid-UIaid20241—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+8K223424Spine Auto ViewsGE Medical Systems SCS20230—
+8K231360Ambra PACSDicom Grid Dba Ambra Health202301
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+8K230012Atomica PlannerAtomica Technology, Inc.20230—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K221677Synapse 3D Base Tools v6.6Fujifilm Corporation20224—
+8K222070EndoNautTherenva Sas20221—
+8K222361AI-Rad Companion (Musculoskeletal)Siemens Medical Solutions USA, Inc.20220—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K220039AutoSegAi Medic, Inc.20221—
+8K220813Art-PlanTherapanacea20224—
+8K220727inHEART MODELSInheart, Sas20221—
+8K212915MVision AI SegmentationMVision AI20221—
+8K213944HealthOSTNanoxai, Ltd.20221—
+8K213411iSR’obot Mona Lisa 2.0Biobot Surgical Pte., Ltd.20211—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212896Visible Patient SuiteVisible Patient, Sas20213—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+8K2116563D Echo v1.1Jointvue, LLC20210—
+8K211098Breast Volume Navigator (BVN) Model G-2000Metritrack, Inc.20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K202084DeepLook PRECISEDeeplook, Inc.20210—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K202990NinesMeasureNines, Inc.20211—
+8K201501VeolityMeVis Medical Solutions AG20210—
+8K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—