510(k) Report

Devices descending from K033412

136 later devices reach Mediclung, Release 1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+8K221501syngo.via View&GOSiemens Healthcare GmbH20222—
+8K214019syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20221—
+8K213096Al-Rad Companion (Pulmonary)Siemens Medical Solutions USA, Inc.20210—
+8K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+8K193294AI-Rad Companion EngineSiemens Medical Solutions USA, Inc.20200—
+8K200899Quantib AI NodeQuantib B.V.20200—
+8K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+8K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+9K263048Syngo Carbon Space (VA4)Siemens Healthineers AG20260—
+9K252571mdprostateMediaire GmbH20260—
+9K260852MAGNETOM Flow.Elite;MAGNETOM Flow.Neo;MAGNETOM Flow.Rise;MAGNETOM Flow.PureSiemens Healthineers AG20260—
+9K253690LungMapsSiemens Healthineers AG20260—
+9K253077uOmnispace.MRShanghai United Imaging Healthcare Co., Ltd.20260—
+9K260167Bunkerhill Contrast AVCBunkerHill Health20260—
+9K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+9K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+9K240294Syngo Carbon Enterprise Access (VA40A)Siemens Healthcare GmbH20240—
+9K232856Syngo Carbon ClinicalsSiemens Healthcare GmbH20231—
+9K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+9K230196syngo.via View&GO VA40ASiemens Healthcare GmbH20231—
+9K221727syngo.CT Extended FunctionalitySiemens Medical Solutions USA, Inc.20220—
+9K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+10K252634Imagine® Enterprise SuiteSoftlink International Private Limited20260—
+10K251059Syngo Carbon Clinicals (VA41)Siemens Healthineers AG20250—
+10K241211CoLumboSmart Soft Healthcare20242—
+10K220497CoLumboSmart Soft Healthcare AD20226—
+10K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+11K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+11K250367CoLumboXSmart Soft Healthcare AD20250—
+11K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+11K240793MSKaiMskai20240—
+11K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+11K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+11K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+12K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—