Cleared Special

K170476 - Nio Color 5.8MP (MDNC-6121)

K170476 is the FDA 510(k) clearance for Nio Color 5.8MP (MDNC-6121) by Barco N.V.. It is a Class 2 Radiology device (product code PGY) cleared through the Special 510(k) pathway after a 40-day FDA review.

K170476 · Barco N.V. · Radiology device
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Mar 2017
Decision
40d
Days
Class 2
Risk

K170476 is an FDA 510(k) clearance for the Nio Color 5.8MP (MDNC-6121). 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 March 28, 2017 after a review of 40 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 K170476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2017
Decision Date March 28, 2017
Days to Decision 40 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 107d · This submission: 40d
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
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K170476.
RadiForce MX194
K180961 · Eizo Corporation · May 2018
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K170837 · Barco N.V. · Apr 2017
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Coronis Uniti
K151505 · Barco N.V. · Jul 2015
Mammography Color Display DP-M3010
K143718 · Canon, Inc. · Jan 2015