510(k) Report

Devices descending from K032428

431 later devices reach Magnetom Avanto MR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K202170LiverMultiScanPerspectum, Ltd.20203—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K200515syngo.CT Cardiac PlanningSiemens Medical Soultions USA, Inc.20200—
+8K200132AshvinsMedicalcommunications GmbH202001
+8K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+8K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+8K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+8K162722HyperSenseGe Medical Systems, LLC20170—
+8K162008JiveXVisus Technology Transfer GmbH20164—
+8K161567SIGNA VoyagerGE Healthcare201644
+8K161397MAGiCGe Medical Systems, LLC20161—
+8K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+8K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+8K151192syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201514—
+8K142647mint LesionMint Medical GmbH201523
+8K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+9K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+9K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+9K230112CAC SoftwareImbio, Inc.20230—
+9K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+9K230223iCAC DeviceBunkerhill, Inc.20236—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+9K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+9K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+9K202229AI MetricsAi Metrics, LLC20200—
+9K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+9K193324Motion Correction SystemKineticor, Inc.20202—
+9K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+9K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+9K181964JiveXVisus Health IT GmbH20183—
+9K162943SyMRISyntheticmr AB20170—
+9K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+9K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+9K160621SIGNAPioneerGE Healthcare201695
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K153003SIGNA PioneerGE Healthcare201505
+10K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—
+10K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K250662Bunkerhill MACBunkerHill Health20250—
+10K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+10K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+10K243229Bunkerhill AVCBunkerHill Health20253—
+10K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+10K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+10K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+10K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+10K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+10K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+10K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+10K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+10K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+10K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+10K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+10K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+10K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+10K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+10K200703JiveXVisus Health IT GmbH20202—
+10K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+10K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+10K171128SIGNA PremierGe Medical Systems, LLC2017118
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+11K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+11K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+11K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+11K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+11K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+11K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.20250—
+11K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+11K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+11K223523Sonic DLGe Medical Systems,Llc (Ge Healthcare)20231—
+11K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—
+11K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.20223Class I
+11K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.20223—
+11K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.20220—
+11K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.202213—
+11K213603SIGNA Artist EvoGe Healthcare (Tianjin) Company Limited202201
+11K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+11K183231SIGNA PremierGe Medical Systems, LLC2019107
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+12K243667Sonic DLGe Medical Systems, LLC20250—