510(k) Report

Devices descending from K981535

354 later devices reach Focus Pilot Contouring Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+6K142196Visage Ease ProVisage Imaging GmbH20150—
+6K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+6K141855ClarityElekta, Ltd.20140—
+6K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+6K113620Myrian 1.11Intrasense20126—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+7K260597Virtue QAProNova Solutions20260—
+7K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+7K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K250039HPACSHealthhub20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K232479ART-PlanTherapanacea20232—
+7K231765Contour ProtégéAIMim Software, Inc.20232—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230575Limbus ContourLimbus Ai, Inc.20231—
+7K221796Cyware 4H and Cysart 4HAbys Medical20221—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+7K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+7K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K212915MVision AI SegmentationMVision AI20221—
+7K220590aPROMISE XExini Diagnostics AB20220—
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K210831OnQ NeuroCortechs Labs, Inc.20213—
+7K212887RTappSegana, Inc.20210—
+7K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202928DV. TargetDeepvoxel, Inc.20210—
+7K203235VBrainVysioneer, Inc.20214—
+7K200822BraidBraid.Health20201—
+7K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+7K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+7K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+7K192424Mobius3DVarian Medical Systems, Inc.20194—
+7K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K182034Arterys MICAArterys, Inc.20183—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173475Merge PACSMerge Healthcare Incorporated201712
+7K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+7K163668SuitestensaEbit Srl20170—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K161130ResolutionMDCalgary Scientific, Inc.20164—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K142142Quality ReportsSun Nuclear Corporation20145—
+7K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K260500ResolutionMDResolutionMD, Inc.20260—
+8K253078ART.1-USSeetreat Pty, Ltd.20260—
+8K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+8K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+8K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+8K252922Neosoma Brain MetsNeosoma, Inc.20250—
+8K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+8K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+8K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K250035Contour ProtégéAI+Mim Software, Inc.20251—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241837Limbus ContourLimbus Ai, Inc.20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+8K231185MapRTVision Rt, Ltd.20231—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K220767TeleScanBb Imaging20221—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—