LEKSELL GAMMA UNIT MODEL 23004,TYPE B.

LEKSELL GAMMA UNIT MODEL 23004,TYPE B. is an FDA 510(k)-cleared medical device (K924849) manufactured by Elekta Radiosurgery, 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 November 19, 1995. Regulation: 8.