Cleared Special

Nio Fusion 12MP (MDNC-12130)

K203106 · Barco N.V. · Radiology

Nov 2020

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K203106 is an FDA 510(k) clearance for the Nio Fusion 12MP (MDNC-12130), 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 November 10, 2020, 26 days after receiving the submission on October 15, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K203106 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 15, 2020
Decision Date	November 10, 2020
Days to Decision	26 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.