510(k) K202294

Affirm Contrast Biopsy by Hologic, Inc. — Product Code IZH

K202294 is an FDA 510(k) premarket notification submitted by Hologic, Inc. for the device "Affirm Contrast Biopsy". The FDA issued a decision of Substantially Equivalent on October 5, 2020. The device falls under product code IZH (System, X-Ray, Mammographic), a Class II device regulated under 21 CFR 892.1710. Hologic, Inc. has at least 10 other 510(k) clearances on record.