SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM

SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM is an FDA 510(k)-cleared medical device (K931298) 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 January 17, 1994. Regulation: 8.