ELK LASER FILM DIGITIZER

ELK LASER FILM DIGITIZER is an FDA 510(k)-cleared medical device (K984409) manufactured by Nishimoto Sangyo Co., Ltd.. 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 11, 1999. Regulation: 8.