SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)

SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER) is an FDA 510(k)-cleared medical device (K965161) manufactured by Sectra-Imtec AB. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 11, 1997. Regulation: 8.