510(k) Report

Devices descending from K191112

2 later devices reach GEHC DXA Bone Densitometers with enCORE version 18 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC20260—
+1K2510223D-Shaper3D-Shaper Medical S.L20250—