510(k) Report

Devices descending from K182904

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253690LungMapsSiemens Healthineers AG20260—
+1K231351Chondral QuantSiemens Medical Soultions USA, Inc.20230—
+1K193290AI-Rad Companion Brain MRSiemens Medical Solutions USA, Inc.202011—
+2K241211CoLumboSmart Soft Healthcare20242—
+2K220497CoLumboSmart Soft Healthcare AD20226—
+2K213706AI-Rad Companion Brain MRSiemens Healthcare GmbH20223—
+3K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+3K250367CoLumboXSmart Soft Healthcare AD20250—
+3K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+3K240793MSKaiMskai20240—
+3K240680CDM InsightsOxford Brain Diagnostics, Ltd.20240—
+3K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+3K232305AI-Rad Companion Brain MRSiemens Medical Solutions U.S.A.20231—
+4K253057AI-Rad Companion Brain MRSiemens Healthcare GmbH20260—