ORACLE MRI WHOLE BODY MR IMAGING SYSTEM

ORACLE MRI WHOLE BODY MR IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K942953) manufactured by Otsuka Electronics USA, Inc.. 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 29, 1994. Regulation: 8.