DX-480, ADD ON DIGITAL IMAGER

DX-480, ADD ON DIGITAL IMAGER is an FDA 510(k)-cleared medical device (K981880) manufactured by Wuestec Medical, 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 October 19, 1998. Regulation: 8.