XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46

XR 46 DXA (CENTRAL) BONE DENSITOMETER, MODEL XR 46 is an FDA 510(k)-cleared medical device (K992125) manufactured by Norland Medical Systems, Inc.. 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 21, 1999. Regulation: 8.