MAMMOMAT 300 AND MAMMOMAT 3000

MAMMOMAT 300 AND MAMMOMAT 3000 is an FDA 510(k)-cleared medical device (K932672) manufactured by Siemens Medical Solutions USA, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1994. Regulation: 8.