LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001

LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 is an FDA 510(k)-cleared medical device (K984328) manufactured by Elekta Instrument AB. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 20, 1999. Regulation: 8.