IMATION SE-204 LASER IMAGER

IMATION SE-204 LASER IMAGER is an FDA 510(k)-cleared medical device (K972822) manufactured by Imation Enterprises Corp.. 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 18, 1997. Regulation: 8.