Cleared Special

K122836 - AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

K122836 is an FDA 510(k) clearance for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM, manufactured by Lorad, A Hologic Co.. The device is a Class 2 Radiology device with product code IZH cleared through the Special 510(k) pathway after a 116-day FDA review.

K122836 · Lorad, A Hologic Co. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
116d
Days
Class 2
Risk

K122836 is an FDA 510(k) clearance for the AFFIRM BREAST BIOPSY GUIDANCE SYSTEM. Classified as System, X-ray, Mammographic (product code IZH), Class II - Special Controls.

Submitted by Lorad, A Hologic Co. (Danbury, US). The FDA issued a Cleared decision on January 11, 2013 after a review of 116 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122836

510(k) Number K122836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2012
Decision Date January 11, 2013
Days to Decision 116 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Modification to existing cleared device.

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 151
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K122836.
Comfort Cover
K161920 · Precision Dynamics Corporation · Jul 2016
Affirm Prone Biopsy System
K153486 · Hologic, Inc. · Apr 2016
MammoGRIP
K152038 · Women'S Imaging Solutions Enterprises, LLC · Dec 2015
SPECBOARD JR.
K123414 · Macbrud Corp., Medical Division · Jan 2013
BIOPSY DIGIT S BIOPSY SL
K113607 · Giotto USA, LLC · Aug 2012
BIOPSY POSITIONER
K113284 · Fuji Film Medical Systems · Mar 2012
K122836 · AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
Download PDF FDA Summary Lorad, A Hologic Co.