510(k) Report

Devices descending from K232086

5 later devices reach spineEOS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240582VEA Align; spineEOSEos Imaging20244—
+2K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+2K251747VEA Align; spineEOSEos Imaging20251—
+3K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+3K251078AutoDensityEos Imaging20250—