510(k) Report

Devices descending from K220497

6 later devices reach CoLumbo through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242607ScanDiags Ortho L-Spine MR-QScandiags AG20250—
+1K240793MSKaiMskai20240—
+1K241108RemedyLogic AI MRI Lumbar Spine ReaderRemedy Logic, Inc.20240—
+1K241211CoLumboSmart Soft Healthcare20242—
+2K254015CoLumbo C-SpineSmart Soft Healthcare AD20260—
+2K250367CoLumboXSmart Soft Healthcare AD20250—