TON-95LH, PAX-I3D ORTHO

TON-95LH, PAX-I3D ORTHO is an FDA 510(k)-cleared medical device (K132983) 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 August 6, 2014. Regulation: 8.