MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205

MAMMOGRAPHY PRO, MODEL 13017, DIAGNOSTIC PRO W/ MAMMOGRAPHY OPTION, MODEL 13205 is an FDA 510(k)-cleared medical device (K993598) manufactured by Vidar Systems 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 January 19, 2000. Regulation: 8.