OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES] is an FDA 510(k)-cleared medical device (K961844) manufactured by Radionics Software Applications, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 22, 1996. Regulation: 8.