DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME)

DIGMI-2000 (GSI INTERNAL REFERENCE)/LD2800 (MARKETING NAME) is an FDA 510(k)-cleared medical device (K973411) manufactured by General Scanning, 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 December 3, 1997. Regulation: 8.