EXL-12SP,12DP,15DP,20DP LINAC

EXL-12SP,12DP,15DP,20DP LINAC is an FDA 510(k)-cleared medical device (K970137) manufactured by Mitsubishi Electronics America, 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 April 14, 1997. Regulation: 8.