510(k) K082317

GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION by General Electric Co. — Product Code KGI

K082317 is an FDA 510(k) premarket notification submitted by General Electric Co. for the device "GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION". The FDA issued a decision of Substantially Equivalent on September 26, 2008. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. General Electric Co. has at least 10 other 510(k) clearances on record.