MAMMOSPOT 3 AND MAMMOSPOT 8

MAMMOSPOT 3 AND MAMMOSPOT 8 is an FDA 510(k)-cleared medical device (K904517) manufactured by American Mammographics, 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 November 14, 1990. Regulation: 8.