DTX-100 BONE DENSITOMETER

DTX-100 BONE DENSITOMETER is an FDA 510(k)-cleared medical device (K963789) manufactured by Osteometer Meditech A/S. 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 13, 1997. Regulation: 8.