M2 WRIST 2 MRI SYSTEM

M2 WRIST 2 MRI SYSTEM is an FDA 510(k)-cleared medical device (K130692) manufactured by Aspect Imaging, Ltd.. 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 13, 2014. Regulation: 8.