Cleared Special

K161229 - Mammo Tomosynthesis (MDMG-5221)

K161229 is the FDA 510(k) clearance for Mammo Tomosynthesis (MDMG-5221) by Barco N.V.. It is a Class 2 Radiology device (product code PGY) cleared through the Special 510(k) pathway after a 16-day FDA review.

K161229 · Barco N.V. · Radiology device
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May 2016
Decision
16d
Days
Class 2
Risk

K161229 is an FDA 510(k) clearance for the Mammo Tomosynthesis (MDMG-5221). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on May 18, 2016 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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 Barco N.V. devices

Submission Details

510(k) Number K161229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2016
Decision Date May 18, 2016
Days to Decision 16 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
91d faster than avg
Panel avg: 107d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.
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 - PGY Display, Diagnostic Radiology

All 82
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