SCANNER-EMI 7020 AND 7020R

SCANNER-EMI 7020 AND 7020R is an FDA 510(k)-cleared medical device (K781936) manufactured by Emi Medical, 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, 1978. Regulation: 8.