IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION)

IMAGESHARE SECONDARY CAPTURE ACQUISITION STATION AND/OR SOFTWARE (1000 FILM DIGITIZER ACQUISITION STATION) is an FDA 510(k)-cleared medical device (K963594) manufactured by Dejarnette Research Systems. This device is classified under the Radiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on November 6, 1996. Regulation: 8.