510(k) Report

Devices descending from K160914

8 later devices reach sterEOS Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172346sterEOS WorkstationEos Imaging201871
+2K240582VEA Align; spineEOSEos Imaging20244—
+2K231917VEA AlignEos Imaging20245—
+2K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+3K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+3K251747VEA Align; spineEOSEos Imaging20251—
+4K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+4K251078AutoDensityEos Imaging20250—