Cleared Special

Coronis Fusion 4MP LED

K143157 · Barco N.V. · Radiology

Nov 2014

Decision

Days

Class 2

Risk

About This 510(k) Submission

K143157 is an FDA 510(k) clearance for the Coronis Fusion 4MP LED, 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 12, 2014, 9 days after receiving the submission on November 3, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K143157 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2014
Decision Date	November 12, 2014
Days to Decision	9 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.