510(k) Report

Devices descending from K980914

405 later devices reach Emory Cardiac Tool Box through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K130393Mirada RTXMirada Medical, Ltd.201336—
+8K123357Onq RTSOncology Systems, Inc.20120—
+8K121663ClarityElekta, Ltd.20121—
+8K122260Aycan MobileAycan Digitalsysteme GmbH20120—
+8K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+8K112930Mobile MimMim Software, Inc.201199—
+8K111694ASTRACandelis, Inc.20115—
+8K102000ImagysKeosys Sas20103—
+8K102687Mirada RTMirada Medical, Ltd.201037—
+8K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+8K093621Syngo.Pet&CT OncologySiemens Medical Solutions USA, Inc.201054—
+8K080325IGROKIgrok, LLC20080—
+9K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+9K251883MIM – LesionID ProMim Software, Inc.20250—
+9K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+9K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+9K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+9K231662Aid-UIaid20241—
+9K232045MeVis Liver SuiteMeVis Medical Solutions AG20230—
+9K230023ART-PlanTherapanacea Sas20233—
+9K223774Contour ProtégéAIMim Software, Inc.20233—
+9K220039AutoSegAi Medic, Inc.20221—
+9K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+9K220727inHEART MODELSInheart, Sas20221—
+9K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+9K212420Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking…Brainlab AG20213—
+9K210916PVmed Contouring SoftwarePerception Vision Medical Technologies Ltd.Co.20210—
+9K211655aPROMISEExini Diagnostics AB20211—
+9K200323AutoContourRadformation, Inc.20207—
+9K201232Limbus ContourLimbus Ai, Inc.20202—
+9K201798myQA iONIba Dosimetry GmbH202011
+9K191610RTappSegana, LLC20191—
+9K191761Mobius3DVarian Medical Systems, Inc.20195—
+9K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+9K190042Brainlab Elements Image Fusion AngioBrainlab AG20190—
+9K182966PLANET Onco DoseDosisoft20191—
+9K182624MIM - MRT DosimetryMim Software, Inc.201853—
+9K182016Simplicit90YMirada Medical, Ltd.20183—
+9K181572Workflow BoxMirada Medical, Ltd.201825—
+9K180815MIM - SPECTRA QuantMim Software, Inc.201854—
+9K173597Scenium VE20 SoftwareSiemens Medical Solutions USA, Inc.20180—
+9K173542Arterys Oncology DLArterys, Inc.20185—
+9K171350Collision CheckRadformation, Inc.20174—
+9K171754NovaPACSNovarad Corporation201741
+9K170434Enterprise Imaging XERO Viewer 8.1Agfa Healthcare N.V.201732
+9K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+9K163539Ez3D-i / E3Ewoosoft Co., Ltd.20161—
+9K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+9K161201ClearRead CTRiverain Technologies, LLC20165—
+9K160108Synapse PACSFujifilm Medical Systems U.S.A, Inc.201684
+9K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+9K143176UltraLinqUltralinq Healthcare Solutions, Inc.20150—
+9K142196Visage Ease ProVisage Imaging GmbH20150—
+9K141536Viewing Client MobileAxon Medical Technologies Corp.20150—
+9K141855ClarityElekta, Ltd.20140—
+9K140960Picture Archiving and Communications SystemHologic, Inc.20143—
+9K133521Aze Phoenix SoftwareAze, Ltd.20140—
+9K133508Resolutionmd MobileCalgary Scientific, Inc.20145—
+9K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+9K123920Syngo.ViaSiemens AG Medical Solutions201363—
+9K123230Mosaiq Oncology Information SystemImpac Medical Systems, Inc.2012207
+9K113620Myrian 1.11Intrasense20126—
+9K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+9K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+9K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+10K260597Virtue QAProNova Solutions20260—
+10K261210Cleerly PlaqueCleerly, Inc.20260—
+10K260588Cleerly LABSCleerly, Inc.20260—
+10K260576MeVis AVM ContourMeVis Medical Solutions AG20260—
+10K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+10K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+10K252547TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation202521
+10K252199AGFA HealthCare Enterprise ImagingAgfa Healthcare N.V.20250—
+10K250039HPACSHealthhub20250—
+10K242919V5med Lung AIV5med, Inc.20250—
+10K241765PLANET Onco Dose (3.2)Dosisoft SA20250—
+10K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc.20250—
+10K232835Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction SystemCanon Medical Systems Corporation20243—
+10K231683inHEART ModelsInheart, Sas20240—
+10K232479ART-PlanTherapanacea20232—
+10K231765Contour ProtégéAIMim Software, Inc.20232—
+10K223106Brainlab Elements Image Fusion, Contouring (4.5);Image Fusion (4.5);Fibertracking…Brainlab AG20231—
+10K230575Limbus ContourLimbus Ai, Inc.20231—
+10K223336Vitrea Software Package, VSTP-002ACanon Medical Systems Corporation20231—
+10K221796Cyware 4H and Cysart 4HAbys Medical20221—
+10K221612ClearRead CTRiverain Technologies, Inc.20220—
+10K220408Aview RT AcsCoreline Soft Co., Ltd.20220—
+10K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+10K220583ClearCheck Model RADCC V2Radformation, Inc.20223—
+10K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+10K212915MVision AI SegmentationMVision AI20221—
+10K220590aPROMISE XExini Diagnostics AB20220—
+10K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+10K210831OnQ NeuroCortechs Labs, Inc.20213—
+10K212887RTappSegana, Inc.20210—
+10K212218Advanced Algorithms for Treatment Management Applications (AATMA)Elekta Solutions AB20210—
+10K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+10K202928DV. TargetDeepvoxel, Inc.20210—
+10K203235VBrainVysioneer, Inc.20214—
+10K200822BraidBraid.Health20201—