510(k) Report

Devices descending from K040172

463 later devices reach Modification to GE Discovery LS System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+8K201103Xeleris V Processing and Review SystemsGE Healthcare20204—
+8K200822BraidBraid.Health20201—
+8K192969Ezra Plexo SoftwareEzra Ai, Inc.20200—
+8K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+8K200304EPIQ Diagnostic Ultrasound SystemPhilips Ultrasound, Inc.2020243
+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
+8K182857EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7…Philips Ultrasound, Inc.20181923
+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
+8K171719Hybrid3DHermes Medical Solutions AB20175—
+8K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+8K163668SuitestensaEbit Srl20170—
+8K163394Hybrid3DHermes Medical Solutions AB20176—
+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—
+9K252477Hybrid Viewer (00859873006240)Hermes Medical Solutions AB20250—
+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—
+9K250416GBrain MRIGalileo Cds, Inc.20251—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+9K241837Limbus ContourLimbus Ai, Inc.20240—
+9K233908cNeuro cDATCombinostics OY20240—
+9K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+9K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+9K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+9K231765Contour ProtégéAIMim Software, Inc.20232—
+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—
+9K221984InterView XP; InterView FUSIONMediso Medical Imaging Systems, Lttd.20230—
+9K221706AccuContourManteia Technologies Co., Ltd.20232—
+9K221680Xeleris V Processing and Review SystemGE Healthcare20231—
+9K220630TorchTM SoftwareVoximetry, Incorporated20221—
+9K2226485000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500…Philips Ultrasound, LLC202212
+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—
+9K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+9K212116VBrain-OARVysioneer, Inc.20211—
+9K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+9K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+9K203669Mobius3DVarian Medical Systems, Inc.20213—
+9K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+9K202216EPIQ Series Diagnostic Ultrasound SystemsPhilips Ultrasound, Inc.2020218
+9K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+9K201012EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series…Philips Ultrasound, Inc.2020185
+9K192437Arterys MICAArterys, Inc.20202—
+9K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+9K192455Merge PACSMerge Healthcare Incorporated201904
+9K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+9K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+9K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+9K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+9K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+9K181468Hybrid3DHermes Medical Solutions AB20184—
+9K181892Ziostation2Ziosoft, Inc.20181—
+9K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+9K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+9K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—