DIGITAL IMAGE SCANNER, MODEL DIS-1000

DIGITAL IMAGE SCANNER, MODEL DIS-1000 is an FDA 510(k)-cleared medical device (K901423) manufactured by Lumisys, 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 April 29, 1990. Regulation: 8.