COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED

COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED is an FDA 510(k)-cleared medical device (K921740) manufactured by Medical Instrumentation & Diagnostics Corp.(Midco). 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 6, 1993. Regulation: 8.