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Lorad, A Hologic Co.
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AFFIRM BREAST BIOPSY GUIDANCE SYSTEM is an FDA 510(k)-cleared medical device (K122836) manufactured by Lorad, A Hologic Co.. 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 10, 2013. Regulation: 8.