510(k) K161682

GE Lunar DXA Bone Densitometers with enCORE version 17 by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC — Product Code KGI

K161682 is an FDA 510(k) premarket notification submitted by GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC for the device "GE Lunar DXA Bone Densitometers with enCORE version 17". The FDA issued a decision of Substantially Equivalent on December 2, 2016. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC has at least 10 other 510(k) clearances on record.