KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER

KODAK EKTASCAN TRIAD LASER PRINTER SYSTEM, PHOTON LASER PRINTER is an FDA 510(k)-cleared medical device (K951807) manufactured by Kodak Health Imaging Systems, 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 September 12, 1995. Regulation: 8.