LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER

LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER is an FDA 510(k)-cleared medical device (K980809) manufactured by Lumisys, 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 May 10, 1998. Regulation: 8.