KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000

KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000 is an FDA 510(k)-cleared medical device (K890097) 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 February 15, 1989. Regulation: 8.