510(k) Report

Devices descending from K001210

242 later devices reach HI-Res 9000 Phased Array Carotid Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+11K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+11K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+11K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+11K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+11K193324Motion Correction SystemKineticor, Inc.20202—
+12K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+12K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+12K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+12K243547uMR UltraShanghai United Imaging Healthcare Co., Ltd.20251—
+12K243397uMR 680Shanghai United Imaging Healthcare Co., Ltd.20251—
+12K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+12K232799syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20242—
+12K233673uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20241—
+12K240540uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20243—
+12K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+12K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+12K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+12K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+12K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+13K260207Multimodality Simulation Workspace (MM Sim) (v1.0.0)Philips Medical Systems Nederland B.V.20260—
+13K260113uMR AstraShanghai United Imaging Healthcare Co., Ltd.20260—
+13K252304syngo.via RT Image Suite VC10Varian Medical Systems, Inc.20260—
+13K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.20250—
+13K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+13K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+13K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—
+13K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.20223Class I
+13K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.20223—
+13K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.20220—
+13K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.202213—
+14K232765MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc.20240—
+14K231587MAGNETOM Cima.XSiemens Medical Solutions USA, Inc.20230Class I
+14K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc.20230Class I
+14K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM…Siemens Medical Solutions USA, Inc.20232Class I
+14K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc.20229—
+15K232535MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc.20234—
+15K232482MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20234—
+16K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+16K240608MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20243—
+17K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20260—