510(k) K133664

ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS by Ge Medical Systems Ultrasound & Primary Care Diagn — Product Code KGI

K133664 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Ultrasound & Primary Care Diagn for the device "ENCORE VERSION 16 SOFTWARE FOR GE LUNAR DXA BONE DENSITOMETERS". The FDA issued a decision of Substantially Equivalent on May 15, 2014. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170.