510(k) Report

Devices descending from K193290

11 later devices reach AI-Rad Companion Brain MR through their predicates, nearest generation first.

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