Cleared Traditional

K123873 - CONTRAST ENHANCED DIGITAL MAMMOGRAPHY

K123873 is an FDA 510(k) clearance for CONTRAST ENHANCED DIGITAL MAMMOGRAPHY, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code MUE cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K123873 · Hologic, Inc. · Radiology device
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Jan 2013
Decision
43d
Days
Class 2
Risk

K123873 is an FDA 510(k) clearance for the CONTRAST ENHANCED DIGITAL MAMMOGRAPHY. Classified as Full Field Digital, System, X-ray, Mammographic (product code MUE), Class II - Special Controls.

Submitted by Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on January 29, 2013 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1715 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K123873

510(k) Number K123873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date January 29, 2013
Days to Decision 43 days
Submission Type Traditional
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
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MUE Device Classification - Class 2, Special Controls

Product Code MUE Full Field Digital, System, X-ray, Mammographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1715
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 - MUE Full Field Digital, System, X-ray, Mammographic

All 54
Devices cleared under the same product code (MUE) and FDA review panel - the closest regulatory comparables to K123873.
ICRCO 3600M
K122510 · Icrco, Inc. · Apr 2013
MAMMOMAL INSPIRATION
K122286 · Siemens Medical Solutions USA, Inc. · Feb 2013
MICRODOSE SI
K123995 · Philips Digital Mammography Sweden AB · Feb 2013
PLANMED NUANCE DIGIGUIDE
K121963 · Planmed OY · Nov 2012
ASPIRE HD PLUS, ASPIRE HD-S
K121674 · Fujifilm Medical System U.S.A., Inc. · Sep 2012
KODAK DIRECTVIEW CR MAMMOGRAPHY SYSTEM (USING CARESTREAM CR MAMMOGRAPHY CASSETTE WITH SNP-M1 SCREEN)
K120246 · Carestream Health, Inc. · Aug 2012