Cleared Special

Nio Color 5.8MP (MDNC-6121)

K170476 · Barco N.V. · Radiology

Mar 2017

Decision

40d

Days

Class 2

Risk

About This 510(k) Submission

K170476 is an FDA 510(k) clearance for the Nio Color 5.8MP (MDNC-6121), 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 28, 2017, 40 days after receiving the submission on February 16, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K170476 FDA.gov
FDA Decision	Cleared 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

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.