FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS

FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS is an FDA 510(k)-cleared medical device (K983262) manufactured by Lunar 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 November 17, 1998. Regulation: 8.