DTX-200 BONE DENSITOMETER

DTX-200 BONE DENSITOMETER is an FDA 510(k)-cleared medical device (K964562) 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 August 21, 1997. Regulation: 8.