510(k) Report

Devices descending from K992450

404 later devices reach Emory Cardiac Toolbox* 2.0 Executing on Nuclear Medicine Computers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+9K191928AccuContourXiamen Manteia Technology, Ltd.202030—
+9K191216Voxel Dosimetry™ v1.0Hermes Medical Solutions AB20195—
+9K192424Mobius3DVarian Medical Systems, Inc.20194—
+9K190694Unifi Workspace v1.0.0Hologic, Inc.20192—
+9K190232Synapse PACSFujifilm Corporation2019311
+9K173001uWS-CTShanghai United Imaging Healthcare Co., Ltd.20185—
+9K172999uWS-MRShanghai United Imaging Healthcare Co., Ltd.20184—
+9K182034Arterys MICAArterys, Inc.20183—
+9K172998uWS-MIShanghai United Imaging Healthcare Co., Ltd.20182—
+9K173863Ez3D-i /E3Ewoosoft Co., Ltd.20180—
+9K173475Merge PACSMerge Healthcare Incorporated201712
+9K171463ASPIRE Bellus IIFujifilm Medical Systems U.S.A, Inc.20170—
+9K163668SuitestensaEbit Srl20170—
+9K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+9K161130ResolutionMDCalgary Scientific, Inc.20164—
+9K150843syngo®.via (version VB10A)Siemens AG201546—
+9K142316IMPAX AgilityAgfa Healthcare N.V.20151—
+9K142142Quality ReportsSun Nuclear Corporation20145—
+9K141572Mosaiq Oncology Information SystemImpac Medical Systems, Inc.20141311
+9K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft20147—
+9K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+9K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+10K260500ResolutionMDResolutionMD, Inc.20260—
+10K253078ART.1-USSeetreat Pty, Ltd.20260—
+10K252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.20260—
+10K253962ClearCheck (RADCC V2.7)Radformation, Inc.20260—
+10K260479TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202611
+10K252922Neosoma Brain MetsNeosoma, Inc.20250—
+10K243919Voxel Dosimetry (00859873006226)Hermes Medical Solutions AB20252—
+10K243647Synapse PACS (7.5)FUJIFILM Healthcare Americas Corporation20251—
+10K243633Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image…Brainlab AG20250—
+10K250427TAIMedImg DeepMetsTaiwan Medical Imaging Co., Ltd.20250—
+10K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+10K243069Lumys (V1)Intradys20250—
+10K250416GBrain MRIGalileo Cds, Inc.20251—
+10K250035Contour ProtégéAI+Mim Software, Inc.20251—
+10K242403Aquilion ONE (TSX-308A/3) V1.5Canon Medical Systems Corporation20242—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241490Contour+ (MVision AI Segmentation)Mvision AI OY20240—
+10K241837Limbus ContourLimbus Ai, Inc.20240—
+10K240705Vitrea Software Package, VSTP-002A V2.0Canon Medical Systems Corporation20240—
+10K234068ART-Plan (v.2.2.0)Therapanacea Sas20240—
+10K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+10K231855QOCA® image Smart RT Contouring SystemQuanta Computer, Inc.20240—
+10K231385Rology Teleradiology Platform (v.1.22.1103)Rology, Inc.20230—
+10K231185MapRTVision Rt, Ltd.20231—
+10K230082Auto SegmentationGe Medical Systems, LLC20231—
+10K230685AutoContour Model RADAC V3Radformation, Inc.20235—
+10K221706AccuContourManteia Technologies Co., Ltd.20232—
+10K220630TorchTM SoftwareVoximetry, Incorporated20221—
+10K220264EFAI RTSuite CT HN-Segmentation SystemEver Fortune.Ai, Co., Ltd.20222—
+10K220767TeleScanBb Imaging20221—
+10K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+10K213628VBrainVysioneer, Inc.20210—
+10K213155RT-Mind-AIMedmind Technology Co., Ltd.20210—
+10K212116VBrain-OARVysioneer, Inc.20211—
+10K203610Automatic Anatomy Recognition (AAR)Quantitative Radiology Solutions, LLC20210—
+10K203669Mobius3DVarian Medical Systems, Inc.20213—
+10K193562AI-Rad Companion Organs RTSiemens Medical Solutions USA, Inc.20206—
+10K192630uWS-MIShanghai United Imaging Healthcare Co., Ltd.20201—
+10K192437Arterys MICAArterys, Inc.20202—
+10K192508Medsynapse Ris Pacs & Medsynapse VNAMedsynaptic Private, Ltd.20190—
+10K192455Merge PACSMerge Healthcare Incorporated201904
+10K183170uWS-CTShanghai United Imaging Healthcare Co., Ltd.20194—
+10K191040syngo.via (Version VB40A)Siemens Healthcare GmbH201910—
+10K183248Synapse Enterprise Viewer Version 1.0Fujifilm Corporation20190—
+10K183164uWS-MRShanghai United Imaging Healthcare Co., Ltd.20193—
+10K183034MOSAIQ Oncology Information SystemElekta, Inc.2018122
+10K181892Ziostation2Ziosoft, Inc.20181—
+10K182208syngo.via View&GO (Version VA10A)Siemens Healthcare GmbH20184—
+10K181185Change Healthcare Enterprise ViewerChange Healthcare Canada Company201802
+10K173635syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20187—
+10K170952syngo.CT View&GOSiemens Medical Solutions USA, Inc.20173—
+10K162655StealthConnect Remote Viewing, Planning and Collaboration SystemMedtronic Navigation, Inc.20170—
+10K163294syngo.MR General, syngo.MR Cardiology, syngo.MR NeurologySiemens Medical Solutions USA, Inc.201723—
+10K162468ClearCheckRadformation20164—
+10K161685syngo®.via protoNeo (Version VA10A)Siemens Healthcare GmbH20161—
+10K151233MonacoImpac Medical Systems, Inc.201569
+10K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+11K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC20260—
+11K253835AffinityHermes Medical Solutions AB20260—
+11K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation20260—
+11K261713Synapse PACS (7.6.0)FUJIFILM Healthcare Americas Corporation20260—
+11K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems Corporation20260—
+11K253270Contour ProtégéAI+Mim Software, Inc.20260—
+11K251351AccuContour 4.0Manteia Technologies Co., Ltd.20260—
+11K250780ARTAssistantManteia Technologies Co., Ltd.20250—
+11K251645Self-Propelled CT Scan Base Kit, CGBA-035A; Alphenix, INFX-8000C/B, INFX-8000C/S, V9.6…Canon Medical Systems Corporation20250—
+11K252362GBrain MRIGalileo Cds, Inc.20250—
+11K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH20252Class I
+11K243301MapRTVision Rt, Ltd.20250—
+11K250099Mobius3D (4.1)Varian Medical Systems20250—
+11K243632uWS-Angio BasicShanghai United Imaging Healthcare Co., Ltd.20250—
+11K242925MR Contour DLGE Healthcare20250—
+11K242994OncoStudio (OS-01)Oncosoft. Co., Ltd.20251—
+11K242729AutoContour (Model RADAC V4)Radformation, Inc.20242—
+11K240411uAI PortalShanghai United Imaging Intelligence Co., Ltd.20240—
+11K233209uOmnispace.CTShanghai United Imaging Healthcare Co., Ltd.20241—
+11K233176uOmnispace.MIShanghai United Imaging Healthcare Co., Ltd.20230—