SC-1000 WITH SUFFIXES (SCAN CONVERTER)

SC-1000 WITH SUFFIXES (SCAN CONVERTER) is an FDA 510(k)-cleared medical device (K890745) manufactured by Eigen. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 13, 1989. Regulation: 8.