GE Lunar DXA Bone Densitometers with enCORE version 17

GE Lunar DXA Bone Densitometers with enCORE version 17 is an FDA 510(k)-cleared medical device (K161682) manufactured by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 1, 2016. Regulation: 8.