510(k) Report

Devices descending from K981217

355 later devices reach Platinum Reading, Review & Analysis Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K230023ART-PlanTherapanacea Sas20233—
+6K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+6K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+6K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K211655aPROMISEExini Diagnostics AB20211—
+6K200323AutoContourRadformation, Inc.20207—
+6K201232Limbus ContourLimbus Ai, Inc.20202—
+6K201798myQA iONIba Dosimetry GmbH202011
+6K192437Arterys MICAArterys, Inc.20202—
+6K191610RTappSegana, LLC20191—
+6K191761Mobius3DVarian Medical Systems, Inc.20195—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+6K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+6K182966PLANET Onco DoseDosisoft20191—
+6K182624MIM - MRT DosimetryMim Software, Inc.201853—
+6K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+6K182016Simplicit90YMirada Medical, Ltd.20183—
+6K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+6K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+6K181572Workflow BoxMirada Medical, Ltd.201825—
+6K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+6K173542Arterys Oncology DLArterys, Inc.20185—
+6K173588Illumeo SystemPhilips Medical Systems Technologies, Ltd.20182—
+6K171350Collision CheckRadformation, Inc.20174—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+6K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K141855ClarityElekta, Ltd.20140—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+6K123920Syngo.ViaSiemens AG Medical Solutions201363—
+6K122205EXINIExini Diagnostics AB20125—
+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
+7K250181AV ViewerPhilips Medical Systems Nederland B.V.20251—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K232479ART-PlanTherapanacea20232—
+7K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+7K230575Limbus ContourLimbus Ai, Inc.20231—
+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—
+7K203744Arterys MICAArterys, Inc.20221—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+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—
+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—
+7K191262aBSIExini Diagnostics AB20192—
+7K190232Synapse PACSFujifilm Corporation2019311
+7K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+7K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+7K173444Quantitative Total Extensible Imaging (QTxI)Aiq Solutions, Inc.20181—
+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—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K261465Indira Cloud ViewerIndigo Technologies20260—
+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—
+8K251883MIM – LesionID ProMim Software, Inc.20250—
+8K252539Tempus PixelArterys, 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—