510(k) Report

Devices descending from K041112

422 later devices reach Magnetom Espree System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K193200uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20208—
+6K192496Magnetom Sola, Magnetom Altea and Magnetom Sola FitSiemens Medical Solutions USA, Inc.20200—
+6K183271AI-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20196—
+6K190017LiverMultiScan (LMSv3)Perspectum Diagnostics, Ltd.20196—
+6K190757MAGNETOM Avanto FitSiemens Medical Solution USA, Inc.20190—
+6K183014uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20193—
+6K183221MAGNETOM Amira, MAGNETOM SempraSiemens Medical Solutions USA, Inc.201961
+6K183272AI Rad Companion (Engine)Siemens Medical Solutions USA, Inc.20192—
+6K182299MAGNETOM AeraSiemens Medical Solutions USA, Inc.20181—
+6K181433MAGNETOM VidaSiemens Medical Solutions USA, Inc.201828—
+6K173637syngo.CT Coronary Analysis; syngo.CT Vascular AnalysisSiemens Medical Solutions USA, Inc.20181—
+6K173617MAGNETOM Vida with Compressed Sensing GRASP-VIBESiemens Medical Solutions USA, Inc.20180—
+6K173224Spin-SwiSpintech, Inc.20183—
+6K173378syngo®.via protoNeo (Version VA20)Siemens Healthcare GmbH20170—
+6K163250Longitudinal Brain Imaging (LoBI) applicationPhilips Medical Systems Nederland B.V.20170—
+6K163619Signa Pet/MRGe Medical Systems, LLC201717
+6K163341syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20176—
+6K161201ClearRead CTRiverain Technologies, LLC20165—
+6K151212Ziostation2Qi Imaging, LLC20152—
+6K151380syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20159—
+6K143251SIGNA Creator, SIGNA ExplorerGe Healthcare (Ge Medical Systems, LLC)2015314
+6K133521Aze Phoenix SoftwareAze, Ltd.20140—
+6K130998Syngo.Via Web ViewerSiemens AG Medical Solutions20140—
+6K132523MyoperfusionToshibamedical Systems Corporation201311
+6K132532Syngo.Plaza VB10ASiemens AG Healthcare2013811
+6K132376Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5TGe Healthcare (Ge Medical Systems, LLC)20134215
+6K123577Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201319—
+6K123585Syngo, CT Cardiac FunctionSiemens Medical Solutions USA, Inc.201214—
+6K113620Myrian 1.11Intrasense20126—
+6K120778Brivo MR355Ge Hangwei Medical Systems Co., Ltd.201204
+6K113490Optima MR450WGe Medical Systems, LLC2012443
+6K112531Vitrea CT Myocardial AnalysisVital Images, Inc.20116—
+6K103335Gem Option for 1.5 Mri SystemsGE Healthcare201133
+7K254075Synapse Lung Nodule AIFujifilm Corporation20260—
+7K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+7K252838MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile; MAGNETOM Vida…Siemens Healthcare GmbH20251—
+7K250367CoLumboXSmart Soft Healthcare AD20250—
+7K242624Medical Image Post-processing Software (uOmnispace.CT)Shanghai United Imaging Healthcare Co., Ltd.20250—
+7K242919V5med Lung AIV5med, Inc.20250—
+7K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+7K240793MSKaiMskai20240—
+7K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+7K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+7K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+7K233080HealthFLDNano-X AI, Ltd.20240—
+7K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+7K232981Synq Software Version 1.3Synaptive Medical, Inc.20230—
+7K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+7K223343MAGNETOM Amira; MAGNETOM SempraSiemens Medical Solutions USA, Inc.202301
+7K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+7K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+7K223439SIGNA VictorGe Healthcare (Tianjin) Company Limited202311
+7K221612ClearRead CTRiverain Technologies, Inc.20220—
+7K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+7K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+7K220910Medical image processing softwareHangzhou Deepwise & League of PHD Technology Co., Ltd.20220—
+7K213713AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20221—
+7K203279Veuron-Brain-mN1Heuron Co., Ltd.20220—
+7K213709Signa Pet/MRGe Medical Systems, LLC202203
+7K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+7K211980SIGNA PrimeGe Healthcare (Tianjin) Company Limited202222
+7K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+7K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+7K210611MAGNETOM Free.MaxSiemens Medical Solutions USA, Inc.202141
+7K210843STAGESpintech, Inc.20211—
+7K201250SQuEEZ SoftwareCardiowise, Inc.20200—
+7K202170LiverMultiScanPerspectum, Ltd.20203—
+7K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+7K192880InferRead Lung CT.AIBeijing Infervision Technology Co., Ltd.20201—
+7K200899Quantib AI NodeQuantib B.V.20200—
+7K192672uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20192—
+7K183268AI-Rad Companion (Cardiovascular)Siemens Medical Solutions USA, Inc.201911—
+7K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+7K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+7K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+7K180563syngo.plazaSiemens Healthcare GmbH20180—
+7K170221syngo.CT Cardiac PlanningSiemens Healthcare GmbH201711
+7K162370syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20168—
+7K160334Advanced Medical Imaging Software Suite (KSWVWR)Keosys Sas20162—
+7K142750JiveXVisus Technology Transfer GmbH20156—
+7K150104Vitrea CT Myocardial PerfusionVital Images, Inc.20150—
+7K142361Discovery MR750 3.0TGe Medical Systems, LLC201402
+7K142085Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5TGe Medical Systems, LLC20144027
+7K133644Syngo.Via MI WorkflowsSiemens Medical Solutions USA, Inc.201418—
+7K130552CT Pulmonary AnalysisQi Imaging, LLC20142—
+7K123522Optima MR450WGe Healthcare (Ge Medical Systems, LLC)2013431
+7K1233271.5T Gem RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20132—
+8K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+8K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+8K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+8K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+8K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+8K240554InferRead Lung CT.AIInfervision Medical Technology Co., Ltd.20250—
+8K250379SIGNA Prime EliteGe Medical Systems, LLC20250—
+8K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+8K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+8K233753AI-Rad Companion (Pulmonary)Siemens Healthcare GmbH20240—
+8K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+8K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+8K222360AI-Rad Companion (Cardiovascular)Siemens Medical Solutions U.S.A.20230—