510(k) Report

Devices descending from K180336

21 later devices reach syngo.MR Applications through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222975Advantis PlatformAdvantis Medical Imaging Single Member P.C.20230—
+1K193283AI-Rad Companion Prostate MRSiemens Medical Solutions USA, Inc.20202—
+1K192462syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.20201—
+1K182904syngo.MR ApplicationsSiemens Medical Solutions USA, Inc.201914—
+2K252571mdprostateMediaire GmbH20260—
+2K253690LungMapsSiemens Healthineers AG20260—
+2K253495syngo.MR Applications (VB80)Siemens Healthineers AG20250—
+2K252608AI-Rad Companion Prostate MRSiemens Healthcare GmbH20250—
+2K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+2K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+3K241211CoLumboSmart Soft Healthcare20242—
+3K220497CoLumboSmart Soft Healthcare AD20226—
+3K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+4K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+4K250367CoLumboXSmart Soft Healthcare AD20250—
+4K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+4K240793MSKaiMskai20240—
+4K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+4K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+4K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+5K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—