SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY

SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY is an FDA 510(k)-cleared medical device (K013636) 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 January 23, 2002. Regulation: 8.