DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION)

DDR WITH DPA AND 30/60 OPTIONS (DIGITAL VIEWSTATION) is an FDA 510(k)-cleared medical device (K942264) manufactured by Eigen Video. 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 19, 1994. Regulation: 8.