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
+1K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+1K020300Northwestern Gated Blood Pool Spect (Numugas)Syntermed, Inc.20021—
+1K014033Emory Cardiac Toolbox 2.1 Executing on Nuclear Medicine ComputersSyntermed, Inc.2002397—
+2K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+2K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+2K042258BP-Spect V1.OSyntermed, Inc.20040—
+2K040141Emory Cardiac Toolbox Version 2.6Syntermed, Inc.2004396—
+3K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+3K061587Fullcard AnalysisGE Healthcare20061—
+3K061370Cardiq FusionGE Healthcare200651—
+3K052379Mim 3.5 (Circa)Mimvista Corp.2005353—
+4K192277CardIQ FlowGE Medical Systems SCS20200—
+4K190379MIM on LinuxMim Software, Inc.201914—
+4K173088Vitrea Software Toshiba Package VSTP-001AToshibamedical Systems Corporation201811—
+4K170841BiopSee, Mobile USMedcom GmbH20170—
+4K163119NaviSuite SSI EditionMedcom GmbH20171—
+4K113543ONDEMAND3DCybermed, Inc.20119—
+4K103465Synapse 3D Cardiac ToolsFujifilm Medical Systems U.S.A, Inc.201120—
+4K092747Philips Comprehensive Cardiac Analysis (Cca) - Plaque Assessment ToolPhilips Medical Systems (Cleveland), Inc.200919—
+4K060816Mim 4.0 (NeuroMimvista Corp.20063501
+5K240786AutoChamberHeartLung Corporation20241—
+5K233620MIM - Centiloid ScalingMim Software, Inc.20240—
+5K223800MIM – Additional TracersMim Software, Inc.20231—
+5K220256MIM-AblationMim Software, Inc.20224—
+5K203142Veuron-Brain-pAbHeuron Co., Ltd.20215—
+5K193252Contour ProtegeAIMim Software, Inc.20206—
+5K182601Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20180—
+5K183013Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20189—
+5K152746Ez3D PlusEwoosoft Co., Ltd.20161—
+5K133654SceniumSiemens Medical Solutions USA, Inc.20143—
+5K132773Sidexis 4Sirona Dental Systems GmbH20131—
+5K131616EZ3D-I, E3Ewoosoft Co., Ltd.20134—
+5K122429Vessel Analysis and Autoplaque for Ors VisualObject Research Systems (Ors), Inc.201216—
+5K120636Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.201219—
+5K071964Mim 4.1 (Seastar)Mimvista Corp.20072872
+5K062163MimviewerMimvista Corp.2006166—
+6K261855Elucid PlaqueIQElucid Bioimaging, Inc.20260—
+6K252029AI-CVDHeartLung Corporation20250—
+6K250755DS Core DiagnosisDentsply Sirona, Inc.20250—
+6K250902HeartFlow AnalysisHeartFlow, Inc.20250—
+6K241524Elucid PlaqueIQElucid Bioimaging, Inc.20240—
+6K232862MIM – Monte Carlo DosimetryMim Software, Inc.20242—
+6K232514MIM – Dose AnalysisMim Software, Inc.20240—
+6K212758AutoplaqueCedars-Sinai Medical Center: Aim20233—
+6K213857HeartFlow AnalysisHeartFlow, Inc.20221—
+6K221405Neurophet SCALE PETNeurophet., Inc.20222—
+6K213801Veuron-Brain-pAb2Heuron Co., Ltd.20221—
+6K210632Contour ProtegeAIMim Software, Inc.20215—
+6K202700ART-PlanTherapanacea20215—
+6K192923Vitrea Software PackageCanon Medical Systems Corporation20208—
+6K190868Cleerly LabsCleerly, Inc.20197—
+6K182855ProKnow DSProknow, LLC20192—
+6K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+6K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+6K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+6K150192SceniumSiemens Medical Solutions USA, Inc.20152—
+6K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+6K120851Communify Pacs ViewerCommunify Health, LLC20130—
+6K111332Clarity Obp SystemElekta, Ltd.20122—
+6K103576Mim 5.2 (Brachy)Mim Software, Inc.201179—
+6K103785Mobile MimMim Software, Inc.2011120—
+6K101707Fulaccess Model 1.0Fulcrum Medical, Inc.20103—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+6K091373Syngo TruedSiemens Medical Solutions USA, Inc.2009200—
+6K081076Velocityais, Velocity AI, Velocityvx, Velocityrt, V-ResponseVelocity Medical Solutions, LLC2008631
+6K070606Visio+CD Viewer# KPSCDVE01Keosys Sas20074—
+6K070248VelocityaisVelocity Medical Solutions, LLC200765—
+7K260497DEEPVESSEL PlaqueKeya Medical Technology Co., Ltd.20260—
+7K252563Neurophet SCALE PETNeurophet., Inc.20260—
+7K252496Neurophet AQUA AD PlusNeurophet., Inc.20261—
+7K251027cvi42 Coronary Plaque Software ApplicationCircle Cardiovascular Imaging, Inc.20250—
+7K251363ProKnow DSElekta Solutions AB20250—
+7K242240CaRi-PlaqueCaristo Diagnostics, Ltd.20251—
+7K243012MIM – Symphony HDR FusionMim Software, Inc.20241—
+7K233572AutofusePymedix20240—
+7K231642Veuron-Brain-pAb3Heuron Co., Ltd.20230—
+7K220813Art-PlanTherapanacea20224—
+7K220779XDMirada Medical, Ltd.20220—
+7K213976Contour ProtégéAIMim Software, Inc.20224—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K202280Cleerly Labs v2.0Cleerly, Inc.20205—
+7K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+7K193498Infinitt RT PACSInfinitt Healthcare Co., Ltd.20200—
+7K180522IGTFusionIgi Technologies20180—
+7K180129Imbio Segmentation Editing Tool softwareImbio, LLC20180—
+7K173636VelocityVarian Medical Systems, Inc.20188—
+7K173420Radiomics App v1.0Microsoft Corp.20174—
+7K172218MIM – Y90 DosimetryMim Software, Inc.201767—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K160371NovaPACSNovarad Corporation20165—
+7K162339SceniumSiemens Medical Solutions USA, Inc.20161—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K153014Mobius3DMobius Medical Systems, LP201613—
+7K151913MIM-Thin Client (mobile)Mim Software, Inc.201668—
+7K143514Panther StereoSeedProwess, Inc.20150—
+7K143397ICIS ViewAgfa Healthcare N.V.20156—
+7K132853NovapacsNovarad Corp.201462
+7K123082Mobilect ViewerNephosity, Inc.20130—
+7K130393Mirada RTXMirada Medical, Ltd.201336—