510(k) Report

Devices descending from K040141

396 later devices reach Emory Cardiac Toolbox Version 2.6 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K182034Arterys MICAArterys, Inc.20183—
+7K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+7K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+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—
+7K161130ResolutionMDCalgary Scientific, Inc.20164—
+7K150843syngo®.via (version VB10A)Siemens AG201546—
+7K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+7K142142Quality ReportsSun Nuclear Corporation20145—
+7K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+7K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+8K260500ResolutionMDResolutionMD, Inc.20260—
+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—
+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—
+8K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K243069Lumys (V1)Intradys20250—
+8K250416GBrain MRIGalileo Cds, Inc.20251—
+8K250035Contour ProtégéAI+Mim Software, Inc.20251—
+8K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+8K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+8K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+8K241837Limbus ContourLimbus Ai, Inc.20240—
+8K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+8K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+8K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+8K231185MapRTVision Rt, Ltd.20231—
+8K230082Auto SegmentationGe Medical Systems, LLC20231—
+8K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+8K221706AccuContourManteia Technologies Co., Ltd.20232—
+8K220630TorchTM SoftwareVoximetry, Incorporated20221—
+8K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+8K220767TeleScanBb Imaging20221—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213628VBrainVysioneer, Inc.20210—
+8K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+8K212116VBrain-OARVysioneer, Inc.20211—
+8K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+8K203669Mobius3DVarian Medical Systems, Inc.20213—
+8K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+8K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+8K192437Arterys MICAArterys, Inc.20202—
+8K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+8K192455Merge PACSMerge Healthcare Incorporated201904
+8K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+8K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+8K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+8K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+8K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+8K181892Ziostation2Ziosoft, Inc.20181—
+8K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+8K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+8K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+8K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+8K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+8K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+8K162468ClearCheckRadformation20164—
+8K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+8K151233MonacoImpac Medical Systems, Inc.201569
+8K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+9K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+9K253835AffinityHermes Medical Solutions AB20260—
+9K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+9K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+9K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+9K253270Contour ProtégéAI+Mim Software, Inc.20260—
+9K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+9K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+9K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+9K252362GBrain MRIGalileo Cds, Inc.20250—
+9K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+9K243301MapRTVision Rt, Ltd.20250—
+9K250099Mobius3D (4.1)Varian Medical Systems20250—
+9K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+9K242925MR Contour DLGE Healthcare20250—
+9K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+9K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+9K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+9K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+9K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—
+9K233634TeleScanBb Imaging20230—
+9K231928EFAI RTSUITE CT HCAP-Segmentation SystemEver Fortune.Ai, Co., Ltd.20231—
+9K230039uOmnispaceShanghai United Imaging Healthcare Co., Ltd.20230—
+9K223834AccuCheckManteia Technologies Co., Ltd.20231—
+9K221305AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20225—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K213665Syngo Carbon Space VA20ASiemens Healthcare GmbH20225—
+9K203744Arterys MICAArterys, Inc.20221—