GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM

GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM is an FDA 510(k)-cleared medical device (K052293) 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 September 20, 2005. Regulation: 8.