ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT

ORTHO SOFTWARE USED W/LUNAR DPX/DPX-L/DPS-@ DESIT is an FDA 510(k)-cleared medical device (K914404) manufactured by Lunar. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 26, 1992. Regulation: 8.