510(k) Report

Devices descending from K060816

350 later devices reach Mim 4.0 (Neuro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+4K133521Aze Phoenix SoftwareAze, Ltd.20140—
+4K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+4K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+4K123920Syngo.ViaSiemens AG Medical Solutions201363—
+4K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+4K113620Myrian 1.11Intrasense20126—
+4K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+4K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+4K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+5K260597Virtue QAProNova Solutions20260—
+5K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+5K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+5K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+5K251883MIM – LesionID ProMim Software, Inc.20250—
+5K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+5K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+5K250039HPACSHealthhub20250—
+5K242919V5med Lung AIV5med, Inc.20250—
+5K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+5K232479ART-PlanTherapanacea20232—
+5K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+5K230575Limbus ContourLimbus Ai, Inc.20231—
+5K223774Contour ProtégéAIMim Software, Inc.20233—
+5K221796Cyware 4H and Cysart 4HAbys Medical20221—
+5K221612ClearRead CTRiverain Technologies, Inc.20220—
+5K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+5K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+5K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+5K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+5K212915MVision AI SegmentationMVision AI20221—
+5K220590aPROMISE XExini Diagnostics AB20220—
+5K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+5K210831OnQ NeuroCortechs Labs, Inc.20213—
+5K212887RTappSegana, Inc.20210—
+5K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+5K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+5K202928DV. TargetDeepvoxel, Inc.20210—
+5K203235VBrainVysioneer, Inc.20214—
+5K200822BraidBraid.Health20201—
+5K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+5K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+5K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+5K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+5K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+5K192424Mobius3DVarian Medical Systems, Inc.20194—
+5K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+5K190232Synapse PACSFujifilm Corporation2019311
+5K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+5K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+5K182034Arterys MICAArterys, Inc.20183—
+5K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+5K173475Merge PACSMerge Healthcare Incorporated201712
+5K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+5K163668SuitestensaEbit Srl20170—
+5K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+5K161130ResolutionMDCalgary Scientific, Inc.20164—
+5K150843syngo®.via (version VB10A)Siemens AG201546—
+5K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+5K142142Quality ReportsSun Nuclear Corporation20145—
+5K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+5K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+5K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+5K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K260500ResolutionMDResolutionMD, Inc.20260—
+6K253078ART.1-USSeetreat Pty, Ltd.20260—
+6K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+6K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+6K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+6K252922Neosoma Brain MetsNeosoma, Inc.20250—
+6K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+6K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+6K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+6K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+6K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+6K243069Lumys (V1)Intradys20250—
+6K250416GBrain MRIGalileo Cds, Inc.20251—
+6K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+6K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+6K241837Limbus ContourLimbus Ai, Inc.20240—
+6K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+6K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+6K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+6K231765Contour ProtégéAIMim Software, Inc.20232—
+6K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+6K231185MapRTVision Rt, Ltd.20231—
+6K230082Auto SegmentationGe Medical Systems, LLC20231—
+6K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+6K221706AccuContourManteia Technologies Co., Ltd.20232—
+6K220630TorchTM SoftwareVoximetry, Incorporated20221—
+6K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+6K220767TeleScanBb Imaging20221—
+6K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+6K213628VBrainVysioneer, Inc.20210—
+6K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+6K212116VBrain-OARVysioneer, Inc.20211—
+6K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+6K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+6K203669Mobius3DVarian Medical Systems, Inc.20213—
+6K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—