X-POSURE SYSTEM VERSION 2 MAMMO

X-POSURE SYSTEM VERSION 2 MAMMO is an FDA 510(k)-cleared medical device (K003656) manufactured by Pronosco A/S. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 14, 2000. Regulation: 8.