510(k) Report

Devices descending from K003408

378 later devices reach CT Cord IQ Option 1.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K171222Vitrea Software Toshiba Package; VSTP-001AToshibamedical Systems Corporation201712—
+6K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+6K160371NovaPACSNovarad Corporation20165—
+6K160666Dentiq3D3D Industrial Imaging Co., Ltd.20160—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K151988Visible Patient SuiteVisible Patient, Sas20154—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K150757syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.201513—
+6K150761Ez3D-i/E3Ewoosoft Co., Ltd.20153—
+6K133677Syngo CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201412—
+6K133648Syngo, CT Dual EnergySiemens Medical Solutions USA, Inc.201416—
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K132902Syngo Dual Energy Software PackageSiemens Medical Solutions USA, Inc.20140—
+6K132813Dual Energy System PackageToshibamedical Systems Corporation20142—
+6K130383Synapse 3D Cardiac ToolsFujifilm Medical System U.S.A., Inc.20135—
+6K130393Mirada RTXMirada Medical, Ltd.201336—
+6K123646Emory Cardiac Toolbox 4.0Syntermed, Inc.20133—
+6K122909Syngo Single Source Dual EngerySiemens Medical Systems, Inc.201213—
+6K113754CFR QuantUniversity of Texas Medical School AT Houston20129—
+6K113620Myrian 1.11Intrasense20126—
+6K120363Syngo RT InterfaceSiemens Medical Solutions USA, Inc.20120—
+6K111861Syngo.MR Onco, Syngo.MR 3D Lesion Segmentation, Syngo.MR Onco EngineSiemens Medical Systems USA20120—
+6K113029Syngo Via MI WorkflowsSiemens Medical Solutions USA, Inc.201120—
+6K112020Syngo.CT Vascular AnalysisSiemens Medi Cal Solutions, Inc.201199—
+6K110494Syngo MBFSiemens Medical Solutions USA, Inc.20116—
+6K102687Mirada RTMirada Medical, Ltd.201037—
+6K101749Syngo Trued SoftwareSiemens Medical Solutions201076—
+6K101228Mirada XDMirada Medical, Ltd.201070—
+7K253786syngo.CT Coronary CockpitSiemens Medical Solutions USA, Inc.20260—
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K251656Careverse CoronaryDoc (Careverse CoronaryDoc)Careverse Technology Pte., Ltd.20250—
+7K251837Salix Coronary Plaque (V1.0.0)Artrya Limited20250—
+7K244012Mosaic (V1.0.1)Navier Medical20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K242338Cleerly LABS (v2.0)Cleerly, Inc.20252—
+7K231731Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee…Mcgovern Medical School20231—
+7K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—
+7K223422Emory Cardiac Toolbox 4.3Syntermed20230—
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220349TeraRecon NeuroTerarecon,Inc.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K220779XDMirada Medical, Ltd.20220—
+7K213370VeriqaPtw-Freiburg Physikalisch-Technische-Werkstaetten202202
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K212896Visible Patient SuiteVisible Patient, Sas20213—
+7K210085HealthCCSngZebra Medical Vision, Ltd.20219—
+7K203699syngo. CT Extended FunctionalitiesSiemens Medical Solutions USA, Inc.20213—
+7K202084DeepLook PRECISEDeeplook, Inc.20210—
+7K203312Vitrea Software Package, VSTP-001ACanon Medical Systems Corporation20217—
+7K202700ART-PlanTherapanacea20215—
+7K203216The Multimodality Advanced Vessel AnalysisPhilips Medical Systems Nederland B.V.20201—
+7K201195syngo.via MI Workflows, syngo MBFSiemens Medical Solutions USA, Inc.20205—
+7K200323AutoContourRadformation, Inc.20207—
+7K200973Synapse 3D Cardiac ToolsFujifilm Corporaton20204—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+7K192402syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20194—
+7K191468syngo.CT Dual EnergySiemens Medical Solutions USA, Inc.20194—
+7K181572Workflow BoxMirada Medical, Ltd.201825—
+7K173542Arterys Oncology DLArterys, Inc.20185—
+7K170816Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature…Brainlab AG20175—
+7K171754NovaPACSNovarad Corporation201741
+7K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+7K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+7K163289syngo. CT Single Source Dual Energy (twin beam)Siemens Medical Solutions USA, Inc., Ultrasound DI20175—
+7K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V.20165—
+7K161157Vitrea CT Dual Energy Image ViewVital Images, Inc.20160—
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K161246Ez3D-i / E3Ewoosoft Co., Ltd.20162—
+7K153220syngo.CT Single Source Dual Energy (Twin Beam)Siemens Medical Solutions USA, Inc.20166—
+7K150745syngo.CT Single Source Dual EnergySiemens Medical Solutions USA, Inc.201511—
+7K143664HeartSeeUniversity of Texas Medical School AT Houston20156—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft20138—
+7K123584Syngo, CT Bone ReadingSiemens Medical Solutions USA, Inc.20138—
+7K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+7K123920Syngo.ViaSiemens AG Medical Solutions201363—
+7K113244Synapse MPR FusionFujifilm Medical System U.S.A., Inc.20119—
+8K261210Cleerly PlaqueCleerly, Inc.20260—
+8K260588Cleerly LABSCleerly, Inc.20260—
+8K252261InferCare RECISTBeijing Infervision Healthcare Medical Technology Co., Ltd.20260—
+8K253735AV VascularPhilips Medical Systems Nederland B.V.20260—
+8K250237InferOperate SuiteBeijing Infervision Healthcare Medical Technology Co., Ltd.20251—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K243881HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow…Bracco Diagnostics, Inc.20250—
+8K241440HealthCCSngNano-X AI, Ltd.20240—
+8K233457RUSHutom, Inc.20240—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K231662Aid-UIaid20241—
+8K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+8K223261Open RibCanon Medical Informatics, Inc.20230—
+8K230112CAC SoftwareImbio, Inc.20230—
+8K230223iCAC DeviceBunkerhill, Inc.20236—
+8K221796Cyware 4H and Cysart 4HAbys Medical20221—
+8K220598AutoContour Model RADAC V2Radformation, Inc.20226—
+8K220039AutoSegAi Medic, Inc.20221—
+8K220813Art-PlanTherapanacea20224—
+8K213504Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package…Canon Medical Systems Corporation20226—
+8K220727inHEART MODELSInheart, Sas20221—