510(k) K161575

Affirm Lateral Arm Upright Biopsy Accessory by Hologic — Product Code IZH

K161575 is an FDA 510(k) premarket notification submitted by Hologic for the device "Affirm Lateral Arm Upright Biopsy Accessory". The FDA issued a decision of Substantially Equivalent on August 10, 2016. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Hologic has at least 10 other 510(k) clearances on record.