510(k) K113286

ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS by Ge Medical Systems Lunar — Product Code KGI

K113286 is an FDA 510(k) premarket notification submitted by Ge Medical Systems Lunar for the device "ENCORE 14 SOFTWARE RELEASE FOR THE GE LUNAR DXA BONE DENSITOMETERS". The FDA issued a decision of Substantially Equivalent on April 27, 2012. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Ge Medical Systems Lunar has at least 1 other 510(k) clearance on record.