510(k) Report

Devices descending from K130395

10 later devices reach Stereos Workstation through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141137Stereos WorkstationEos Imaging20149—
+2K160914sterEOS WorkstationEos Imaging, Inc.20168—
+3K172346sterEOS WorkstationEos Imaging201871
+4K240582VEA Align; spineEOSEos Imaging20244—
+4K231917VEA AlignEos Imaging20245—
+4K193042Optimized Positioning System (OPS) ReViewCorin USA20200—
+5K252103Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20251—
+5K251747VEA Align; spineEOSEos Imaging20251—
+6K260322Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)Mighty Oak Medical20260—
+6K251078AutoDensityEos Imaging20250—