KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP

KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP is an FDA 510(k)-cleared medical device (K904590) manufactured by Eastman Kodak Company. 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 12, 1990. Regulation: 8.