Cleared Traditional

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)

K191845 · Barco N.V. · Radiology

Sep 2019

Decision

58d

Days

Class 2

Risk

About This 510(k) Submission

K191845 is an FDA 510(k) clearance for the Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT), 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 September 6, 2019, 58 days after receiving the submission on July 10, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K191845 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 10, 2019
Decision Date	September 06, 2019
Days to Decision	58 days
Submission Type	Traditional
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.