510(k) Report

Devices descending from K014033

397 later devices reach Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine Computers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+6K080325IGROKIgrok, LLC20080—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K251883MIM – LesionID ProMim Software, Inc.20250—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K231662Aid-UIaid20241—
+7K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+7K230023ART-PlanTherapanacea Sas20233—
+7K223774Contour ProtégéAIMim Software, Inc.20233—
+7K220039AutoSegAi Medic, Inc.20221—
+7K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+7K220727inHEART MODELSInheart, Sas20221—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+7K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+7K211655aPROMISEExini Diagnostics AB20211—
+7K200323AutoContourRadformation, Inc.20207—
+7K201232Limbus ContourLimbus Ai, Inc.20202—
+7K201798myQA iONIba Dosimetry GmbH202011
+7K191610RTappSegana, LLC20191—
+7K191761Mobius3DVarian Medical Systems, Inc.20195—
+7K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+7K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+7K182966PLANET Onco DoseDosisoft20191—
+7K182624MIM - MRT DosimetryMim Software, Inc.201853—
+7K182016Simplicit90YMirada Medical, Ltd.20183—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+7K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K171350Collision CheckRadformation, Inc.20174—
+7K171754NovaPACSNovarad Corporation201741
+7K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+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—
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+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—
+8K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+8K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+8K231683inHEART ModelsInheart, Sas20240—
+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—
+8K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+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—
+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—