PROWESS PANTHER PROARC, MODEL VERSION 5.0

PROWESS PANTHER PROARC, MODEL VERSION 5.0 is an FDA 510(k)-cleared medical device (K101076) manufactured by Prowess, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2010. Regulation: 8.