ANZAI AZ-733 RESPIRATORY GATING SYSTEM

ANZAI AZ-733 RESPIRATORY GATING SYSTEM is an FDA 510(k)-cleared medical device (K031385) manufactured by Anzai Medical 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 November 9, 2003. Regulation: 8.