MODIFICATION TO PROWESS PRO-SIM

MODIFICATION TO PROWESS PRO-SIM is an FDA 510(k)-cleared medical device (K984196) manufactured by Ssgi Prowess Systems. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 1998. Regulation: 8.