Cleared Special

Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)

K230520 · Barco N.V. · Radiology

Mar 2023

Decision

22d

Days

Class 2

Risk

About This 510(k) Submission

K230520 is an FDA 510(k) clearance for the Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521), a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on March 21, 2023, 22 days after receiving the submission on February 27, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K230520 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2023
Decision Date	March 21, 2023
Days to Decision	22 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	PGY — Display, Diagnostic Radiology
Device Class	Class II — 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.