BRAINLAB LINAC HARDWARE

BRAINLAB LINAC HARDWARE is an FDA 510(k)-cleared medical device (K934657) manufactured by Brainlab Med. Computersysteme GmbH. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1994. Regulation: 8.