TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM

TEC 2750 PHOENIX DEDICATED MAMMOGRAPHIC SYSTEM is an FDA 510(k)-cleared medical device (K892342) manufactured by Bay Shore Medical Equipment Corp.. 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 16, 1989. Regulation: 8.