Cleared Special

K103512 - AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

K103512 is the FDA 510(k) clearance for AFFIRM BREAST BIOPSY GUIDANCE SYSTEM by Hologic, Inc.. It is a Class 2 Radiology device (product code IZH) cleared through the Special 510(k) pathway after a 38-day FDA review.

K103512 · Hologic, Inc. · Radiology device
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Jan 2011
Decision
38d
Days
Class 2
Risk

K103512 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 Hologic, Inc. (Danbury, US). The FDA issued a Cleared decision on January 7, 2011 after a review of 38 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Hologic, Inc. devices

Submission Details

510(k) Number K103512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2010
Decision Date January 07, 2011
Days to Decision 38 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
69d faster than avg
Panel avg: 107d · This submission: 38d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 43
Devices cleared under the same product code (IZH) and FDA review panel - the closest regulatory comparables to K103512.
Affirm Contrast Biopsy
K202294 · Hologic, Inc. · Oct 2020
Biopsy Positioner
K191495 · Fujifilm Corporation · Jul 2019
Affirm Prone Biopsy System
K153486 · Hologic, Inc. · Apr 2016
DIGITAL SPOT MAMMOGRAPHY SYSTEM
K100692 · Hologic, Inc. · Apr 2010
MAMMOTEST
K042095 · Fischer Imaging Corp. · Oct 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · Hologic, Inc. · Apr 2004