PAX-FLEX3D, PHT-7000

PAX-FLEX3D, PHT-7000 is an FDA 510(k)-cleared medical device (K121412) manufactured by VATECH Co., Ltd.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 7, 2012. Regulation: 8.