Cleared Traditional

Affirm Prone Biopsy System

K153486 · Hologic, Inc. · Radiology
Apr 2016
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K153486 is an FDA 510(k) clearance for the Affirm Prone Biopsy System, 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 April 1, 2016, 119 days after receiving the submission on December 4, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K153486 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2015
Decision Date April 01, 2016
Days to Decision 119 days
Submission Type Traditional
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