Cleared Special

K171812 - Nio Color 2MP (MDNC-2123)

K171812 is an FDA 510(k) clearance for Nio Color 2MP (MDNC-2123), manufactured by Barco N.V.. The device is a Class 2 Radiology device with product code PGY cleared through the Special 510(k) pathway after a 30-day FDA review.

K171812 · Barco N.V. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
30d
Days
Class 2
Risk

K171812 is an FDA 510(k) clearance for the Nio Color 2MP (MDNC-2123). 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 July 19, 2017 after a review of 30 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.

FDA 510(k) Submission Details - K171812

510(k) Number K171812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2017
Decision Date July 19, 2017
Days to Decision 30 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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

PGY Device Classification - Class 2, Special Controls

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 137
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K171812.
2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
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RadiForce RX560, RX560-AR
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2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
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DELL UP3017 with QUBYX PerfectLum bundle
K171229 · Qubyx Software Technologies, Inc. · May 2017
LCD Monitor (MD310C, MD310G, MD210G)
K170944 · Benq Corporation · May 2017
RadiForce MX315W
K170949 · Eizo Corporation · Apr 2017
K171812 · Nio Color 2MP (MDNC-2123)
Download PDF FDA Summary Barco N.V.