Cleared Special

Affirm Contrast Biopsy

K202294 · Hologic, Inc. · Radiology
Oct 2020
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K202294 is an FDA 510(k) clearance for the Affirm Contrast Biopsy, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on October 5, 2020, 53 days after receiving the submission on August 13, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K202294 FDA.gov
FDA Decision Cleared SESE
Date Received August 13, 2020
Decision Date October 05, 2020
Days to Decision 53 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZH — System, X-ray, Mammographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1710