Affirm Lateral Arm Upright Biopsy Accessory

Affirm Lateral Arm Upright Biopsy Accessory is an FDA 510(k)-cleared medical device (K161575) manufactured by Hologic. 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, 2016. Regulation: 8.