510(k) K901832

GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 by Amersham Corp. — Product Code KGI

K901832 is an FDA 510(k) premarket notification submitted by Amersham Corp. for the device "GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415". The FDA issued a decision of Substantially Equivalent on July 9, 1990. The device falls under product code KGI (Densitometer, Bone), a Class II device regulated under 21 CFR 892.1170. Amersham Corp. has at least 10 other 510(k) clearances on record.