1.5T INFINITY TWINSPEED MR SYSTEM

1.5T INFINITY TWINSPEED MR SYSTEM is an FDA 510(k)-cleared medical device (K012200) 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 August 2, 2001. Regulation: 8.