PROTURA COUCH SOFTWARE

PROTURA COUCH SOFTWARE is an FDA 510(k)-cleared medical device (K122201) manufactured by Med-Tec, Inc. D/B/A Civco Medical Solutions. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 29, 2012. Regulation: 8.