SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM

SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM is an FDA 510(k)-cleared medical device (K992135) manufactured by Ge Medical Systems, 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 September 7, 1999. Regulation: 8.