ADVANTX 1824 SPOTFILM DEVICE

ADVANTX 1824 SPOTFILM DEVICE is an FDA 510(k)-cleared medical device (K950317) manufactured by GE Medical Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 7, 1995. Regulation: 8.