Cleared Traditional

K153486 - Affirm Prone Biopsy System

K153486 is an FDA 510(k) clearance for Affirm Prone Biopsy System, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code IZH cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

K153486 is an FDA 510(k) clearance for the Affirm Prone Biopsy System. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on April 1, 2016 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1710 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K153486

510(k) Number K153486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 107d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZH Device Classification - Class 2, Special Controls

Product Code IZH System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IZH System, X-ray, Mammographic

All 109
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K153486.
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
Affirm Lateral Arm Upright Biopsy Accessory
K161575 · Hologic · Aug 2016
Comfort Cover
K161920 · Precision Dynamics Corporation · Jul 2016
MammoGRIP
K152038 · Women'S Imaging Solutions Enterprises, LLC · Dec 2015
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K122836 · Lorad, A Hologic Co. · Jan 2013
SPECBOARD JR.
K123414 · Macbrud Corp., Medical Division · Jan 2013