SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT

SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT is an FDA 510(k)-cleared medical device (K921941) manufactured by General Electric Co.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 1992. Regulation: 8.