510(k) Report

Devices descending from K993731

440 later devices reach Sonata Gradients/Magnetom Symphony System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+9K240793MSKaiMskai20240—
+9K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+9K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+9K241440HealthCCSngNano-X AI, Ltd.20240—
+9K233186uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20241—
+9K231631BriefCase-QuantificationAidoc Medical, Ltd.20230—
+9K231617MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Medical Solutions USA, Inc.20232—
+9K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+9K230112CAC SoftwareImbio, Inc.20230—
+9K230758uMR 570Shanghai United Imaging Healthcare Co., Ltd.20230—
+9K230223iCAC DeviceBunkerhill, Inc.20236—
+9K230561Syngo Carbon Space VA30ASiemens Healthcare GmbH20234—
+9K222755uMR 680Shanghai United Imaging Intelligence Co., Ltd.20233—
+9K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+9K220929ExcelsiorMerit Cro, Inc.20220—
+9K220332uMR Omega with uWS-MR-MRSShanghai United Imaging Healthcare Co., Ltd.20227—
+9K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K220590aPROMISE XExini Diagnostics AB20220—
+9K211379syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.202142
+9K202229AI MetricsAi Metrics, LLC20200—
+9K202170LiverMultiScanPerspectum, Ltd.20203—
+9K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+9K200899Quantib AI NodeQuantib B.V.20200—
+9K190138MAGNETOM AeraSiemens Medical Solutions USA, Inc.20190—
+9K183244MAGNETOM LuminaSiemens Medical Solutions USA, Inc.20190Class I
+9K183254Magnetom VidaSiemens Medical Solutions USA, Inc.201926—
+9K181964JiveXVisus Health IT GmbH20183—
+9K162722HyperSenseGe Medical Systems, LLC20170—
+9K161567SIGNA VoyagerGE Healthcare201644
+9K161397MAGiCGe Medical Systems, LLC20161—
+9K160618Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5TGe Medical Systems, LLC20161640
+9K160426syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201612—
+9K160317syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.20160—
+9K143345SIGNA PioneerGe Healthcare Japan Corporation2015156
+9K1433893.0T GEM RT Open ArrayGe Healthcare Coils (Usa Instruments, Inc.)20151—
+10K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+10K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+10K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+10K260166Bunkerhill Contrast CACBunkerHill Health20260—
+10K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+10K251822MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+10K250662Bunkerhill MACBunkerHill Health20250—
+10K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+10K243229Bunkerhill AVCBunkerHill Health20253—
+10K242188ClearRead CT CACRiverain Technologies, Inc.20240—
+10K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+10K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…Neocoil, LLC20220—
+10K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+10K200703JiveXVisus Health IT GmbH20202—
+10K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+10K193324Motion Correction SystemKineticor, Inc.20202—
+10K192426Signa Voyager, Signa Voyager QuantumGe Healthcare (Tianjin) Company Limited201914
+10K183621EMMA 1.5T MRI SystemTime Medical Limited20191—
+10K162943SyMRISyntheticmr AB20170—
+10K163331Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T…Ge Medical Systems, LLC20171536
+10K16320548CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20173—
+10K163421syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201711—
+10K160621SIGNAPioneerGE Healthcare201695
+10K153003SIGNA PioneerGE Healthcare201505
+11K260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance, Ltd.20260—
+11K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+11K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+11K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+11K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+11K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+11K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+11K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+11K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+11K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+11K233728SIGNA ChampionGe Healthcare (Tianjin) Company Limited20240—
+11K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+11K222259NEONA 1.5T MRI SystemTime Medical Limited20230—
+11K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+11K213668SIGNA HeroGe Healthcare (Ge Medical Systems, LLC)202232
+11K212321JiveX (Model Number / Release: 5.3)Visus Health IT GmbH20211—
+11K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+11K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+11K202966SIGNA ArchitectGe Healthcare (Ge Medical Systems, LLC)202008
+11K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+11K202238SIGNA ArtistGe Healthcare (Tianjin) Company Limited202015
+11K183186Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4…Shanghai United Imaging Healthcare Co., Ltd.20190—
+11K18066648CH Head CoilGe Healthcare Coils (Usa Instruments, Inc.)20181—
+11K173897syngo.via MI WorkflowsSiemens Medical Solutions USA, Inc.201810—
+11K171128SIGNA PremierGe Medical Systems, LLC2017118
+12K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+12K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+12K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+12K2537383.0T Air 32CH HnaGe Healthcare Coils (Usa Instruments, Inc.)20260—
+12K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.20250—
+12K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+12K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—