BIOPSY DIGIT S BIOPSY SL

BIOPSY DIGIT S BIOPSY SL is an FDA 510(k)-cleared medical device (K113607) manufactured by Giotto USA, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 9, 2012. Regulation: 8.