GE 1.5T SIGNA HDE MR SYSTEM

GE 1.5T SIGNA HDE MR SYSTEM is an FDA 510(k)-cleared medical device (K052978) manufactured by Ge Medical Systems, LLC. 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, 2005. Regulation: 8.