
Mtechgroup
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PHT-6500; PHT-60CFO; PAX-I3D is an FDA 510(k)-cleared medical device (K122606) manufactured by Mtechgroup. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2012. Regulation: 8.