Cleared Traditional

Affirm Lateral Arm Upright Biopsy Accessory

K161575 · Hologic · Radiology
Aug 2016
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K161575 is an FDA 510(k) clearance for the Affirm Lateral Arm Upright Biopsy Accessory, a System, X-ray, Mammographic (Class II — Special Controls, product code IZH), submitted by Hologic (Danbury, US). The FDA issued a Cleared decision on August 10, 2016, 64 days after receiving the submission on June 7, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1710.

Submission Details

510(k) Number K161575 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 2016
Decision Date August 10, 2016
Days to Decision 64 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