Cleared Traditional

K191845 - Coronis Fusion 6MP - MDCC-6530

K191845 is the FDA 510(k) clearance for Coronis Fusion 6MP - MDCC-6530 by Barco N.V.. It is a Class 2 Radiology device (product code PGY) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K191845 · Barco N.V. · Radiology device
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Optimized for regulatory review, auditing and printing
Sep 2019
Decision
58d
Days
Class 2
Risk

K191845 is an FDA 510(k) clearance for the Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Wor.... Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on September 6, 2019 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Barco N.V. devices

Submission Details

510(k) Number K191845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PGY Display, Diagnostic Radiology
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - PGY Display, Diagnostic Radiology

All 82
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