510(k) Report

Devices descending from K010570

254 later devices reach Breast Immobiization and Biopsy Device MR-Biopsy 160 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K243122uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20252—
+10K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+10K240793MSKaiMskai20240—
+10K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+10K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+10K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+10K240744uMR 680Shanghai United Imaging Healthcare Co., Ltd.20242—
+10K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+10K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+10K230152uMR OmegaShanghai United Imaging Healthcare Co., Ltd.20236—
+10K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+10K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20221—
+10K220783syngo.via RT Image SuiteSiemens Medical Solutions USA, Inc.20223—
+10K213960LiverMultiScan v5 (LMSv5)Perspectum20221—
+10K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+10K203280Hepatica v1 (Hepatica v1.0.0)Perspectum, Ltd.20210—
+10K192924MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida FitSiemens Medical Solutions USA, Inc.202022Class I
+10K193324Motion Correction SystemKineticor, Inc.20202—
+11K253413LiverMultiScan (v6.0)Perspectum, Ltd.20260—
+11K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—
+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—
+11K234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.20240—
+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—
+11K213805MAGNETOM VidaSiemens Medical Solutions USA, Inc.20230—
+11K220939MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50ASiemens Medical Solutions USA, Inc.20220Class I
+11K203451TCL3 Motion Tracking SystemTracinnovations Aps20211—
+11K203443MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM AlteaSiemens Medical Solutions USA, Inc.202120Class I
+11K202014Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fitSiemens Medical Solutions USA, Inc.20200Class I
+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—
+12K252371uMR 680Shanghai United Imaging Healthcare Co., Ltd.20250—
+12K250246uMR JupiterShanghai United Imaging Healthcare Co., Ltd.20250—
+12K241069iLoop Interventional Coil 0.55TNoras Mri Products GmbH20240—
+12K221785TCL3 Motion Tracking SystemTracinnovations A/S20220—
+12K220589MAGNETOM Skyra FitSiemens Medical Solutions USA, Inc.20223Class I
+12K220151MAGNETOM Avanto FitSiemens Medical Solutions USA, Inc.20223—
+12K220425MAGNETOM Vida, MAGNETOM SolaSiemens Medical Solutions USA, Inc.20220—
+12K213693MAGNETOM Vida with syngo MR XA50ASiemens Medical Solutions USA, Inc.202213—
+13K232765MAGNETOM Cima.X FitSiemens Medical Solutions USA, Inc.20240—
+13K231587MAGNETOM Cima.XSiemens Medical Solutions USA, Inc.20230Class I
+13K232494MAGNETOM Avanto fit; MAGNETOM Skyra fitSiemens Medical Solutions USA, Inc.20230Class I
+13K231560MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM…Siemens Medical Solutions USA, Inc.20232Class I
+13K221733MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola FitSiemens Medical Solutions USA, Inc.20229—
+14K232535MAGNETOM Sola; MAGNETOM AlteaSiemens Medical Solutions USA, Inc.20234—
+14K232482MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20234—
+15K250436MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20251—
+15K240608MAGNETOM Viato.MobileSiemens Medical Solutions USA, Inc.20243—
+16K260265MAGNETOM Flow.Ace; MAGNETOM Flow.PlusSiemens Shenzhen Magnetic Resonance, Ltd.20260—