510(k) Report

Devices descending from K003358

355 later devices reach QPS (Quantitative Perfusion Spect), QGS (Quantitative Gated Spect) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K161201ClearRead CTRiverain Technologies, LLC20165—
+7K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+7K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+7K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+7K142196Visage Ease ProVisage Imaging GmbH20150—
+7K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+7K141855ClarityElekta, Ltd.20140—
+7K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+7K133521Aze Phoenix SoftwareAze, Ltd.20140—
+7K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+7K113620Myrian 1.11Intrasense20126—
+7K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+7K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+7K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+8K260597Virtue QAProNova Solutions20260—
+8K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+8K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+8K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+8K250039HPACSHealthhub20250—
+8K242919V5med Lung AIV5med, Inc.20250—
+8K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+8K232479ART-PlanTherapanacea20232—
+8K231765Contour ProtégéAIMim Software, Inc.20232—
+8K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+8K230575Limbus ContourLimbus Ai, Inc.20231—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K221612ClearRead CTRiverain Technologies, Inc.20220—
+8K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+8K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+8K212915MVision AI SegmentationMVision AI20221—
+8K220590aPROMISE XExini Diagnostics AB20220—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K210831OnQ NeuroCortechs Labs, Inc.20213—
+8K212887RTappSegana, Inc.20210—
+8K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+8K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+8K202928DV. TargetDeepvoxel, Inc.20210—
+8K203235VBrainVysioneer, Inc.20214—
+8K200822BraidBraid.Health20201—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+8K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+8K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+8K192424Mobius3DVarian Medical Systems, Inc.20194—
+8K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+8K190232Synapse PACSFujifilm Corporation2019311
+8K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+8K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+8K182034Arterys MICAArterys, Inc.20183—
+8K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+8K173475Merge PACSMerge Healthcare Incorporated201712
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K163668SuitestensaEbit Srl20170—
+8K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+8K161130ResolutionMDCalgary Scientific, Inc.20164—
+8K150843syngo®.via (version VB10A)Siemens AG201546—
+8K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+8K142142Quality ReportsSun Nuclear Corporation20145—
+8K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+8K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+8K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+8K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+9K260500ResolutionMDResolutionMD, Inc.20260—
+9K253078ART.1-USSeetreat Pty, Ltd.20260—
+9K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+9K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+9K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+9K252922Neosoma Brain MetsNeosoma, Inc.20250—
+9K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+9K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+9K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+9K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+9K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+9K243069Lumys (V1)Intradys20250—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K250035Contour ProtégéAI+Mim Software, Inc.20251—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241837Limbus ContourLimbus Ai, Inc.20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+9K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+9K231185MapRTVision Rt, Ltd.20231—
+9K230082Auto SegmentationGe Medical Systems, LLC20231—
+9K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+9K221706AccuContourManteia Technologies Co., Ltd.20232—
+9K220630TorchTM SoftwareVoximetry, Incorporated20221—
+9K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+9K220767TeleScanBb Imaging20221—
+9K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+9K213628VBrainVysioneer, Inc.20210—