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
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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.

View all Lorad, A Hologic Co. devices

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
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 82
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K122836.
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
Affirm Prone Biopsy System
K153486 · Hologic, Inc. · Apr 2016
AFFIRM BREAST BIOPSY GUIDANCE SYSTEM
K103512 · Hologic, Inc. · Jan 2011
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
PLANMED SOPHIE NUANCE CLASSIC
K042671 · Planmed OY · Nov 2004