Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is an FDA 510(k)-cleared medical device (K201840) manufactured by Rebound Therapeutics. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 3, 2020. Regulation: 8.