510(k) Report

Devices descending from K013531

307 later devices reach Qwiksim Virtual Simulation System; Version 2.00 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+6K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+6K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+6K242919V5med Lung AIV5med, Inc.20250—
+6K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+6K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+6K232479ART-PlanTherapanacea20232—
+6K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+6K230575Limbus ContourLimbus Ai, Inc.20231—
+6K221612ClearRead CTRiverain Technologies, Inc.20220—
+6K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+6K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+6K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+6K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+6K212915MVision AI SegmentationMVision AI20221—
+6K220590aPROMISE XExini Diagnostics AB20220—
+6K213976Contour ProtégéAIMim Software, Inc.20224—
+6K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+6K210831OnQ NeuroCortechs Labs, Inc.20213—
+6K212887RTappSegana, Inc.20210—
+6K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+6K211881AI SegmentationVarian Medical Systems, Inc.20210—
+6K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+6K202928DV. TargetDeepvoxel, Inc.20210—
+6K203235VBrainVysioneer, Inc.20214—
+6K201444Syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20205—
+6K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+6K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+6K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+6K192424Mobius3DVarian Medical Systems, Inc.20194—
+6K190178Monaco RTP SystemElekta, Inc.201945
+6K190232Synapse PACSFujifilm Corporation2019311
+6K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+6K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+6K182034Arterys MICAArterys, Inc.20183—
+6K182050Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy…Siemens Medical Solutions USA, Inc.20180—
+6K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+6K173475Merge PACSMerge Healthcare Incorporated201712
+6K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+6K163668SuitestensaEbit Srl20170—
+6K150843syngo®.via (version VB10A)Siemens AG201546—
+6K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+6K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K253078ART.1-USSeetreat Pty, Ltd.20260—
+7K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+7K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+7K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+7K252922Neosoma Brain MetsNeosoma, Inc.20250—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+7K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+7K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+7K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+7K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+7K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+7K250416GBrain MRIGalileo Cds, Inc.20251—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+7K241837Limbus ContourLimbus Ai, Inc.20240—
+7K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+7K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+7K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+7K231185MapRTVision Rt, Ltd.20231—
+7K230082Auto SegmentationGe Medical Systems, LLC20231—
+7K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K221706AccuContourManteia Technologies Co., Ltd.20232—
+7K220630TorchTM SoftwareVoximetry, Incorporated20221—
+7K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K213628VBrainVysioneer, Inc.20210—
+7K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+7K212116VBrain-OARVysioneer, Inc.20211—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+7K202789Monaco Rtp SystemElekta Solutions AB20213—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K203669Mobius3DVarian Medical Systems, Inc.20213—
+7K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+7K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+7K192437Arterys MICAArterys, Inc.20202—
+7K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+7K192455Merge PACSMerge Healthcare Incorporated201904
+7K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+7K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+7K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+7K181892Ziostation2Ziosoft, Inc.20181—
+7K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+7K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+7K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+7K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+8K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+8K253835AffinityHermes Medical Solutions AB20260—
+8K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+8K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+8K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—