Q. FREEZE (MOTION VUE2)

Q. FREEZE (MOTION VUE2) is an FDA 510(k)-cleared medical device (K113408) 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 February 23, 2012. Regulation: 8.