ADVANTX AFM ANGIO SYSTEM S1808

ADVANTX AFM ANGIO SYSTEM S1808 is an FDA 510(k)-cleared medical device (K905653) 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 May 14, 1991. Regulation: 8.