GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415

GADOLINIUM-153 BONE DENSITOMETER SOURCES GDC.10415 is an FDA 510(k)-cleared medical device (K901832) manufactured by Amersham Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 8, 1990. Regulation: 8.