RALCO, MODEL R225 ACS

RALCO, MODEL R225 ACS is an FDA 510(k)-cleared medical device (K091517) manufactured by Ralco S.R.L.. 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 13, 2009. Regulation: 8.