DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.)

DIGITAL 8 W/OTHER NUMERICAL SUFFIXES (1-9, ETC.) is an FDA 510(k)-cleared medical device (K901956) manufactured by Eigen. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 1, 1990. Regulation: 8.