BONE MINERAL DENSITOMETRY OPTION B7918AA

BONE MINERAL DENSITOMETRY OPTION B7918AA is an FDA 510(k)-cleared medical device (K863618) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 8, 1987. Regulation: 8.