Cleared Special

K262412 - Coronis Fusion 4MP (MDCC-4630)

Also marketed or referenced as:
Coronis Fusion 6MP (MDCC-6630)

K262412 is an FDA 510(k) clearance for Coronis Fusion 4MP (MDCC-4630), manufactured by Barco NV. The device is a Class 2 Radiology device with product code PGY cleared through the Special 510(k) pathway after a 79-day FDA review.

K262412 · Barco NV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
79d
Days
Class 2
Risk

K262412 is an FDA 510(k) clearance for the Coronis Fusion 4MP (MDCC-4630). Classified as Display, Diagnostic Radiology (product code PGY), Class II - Special Controls.

Submitted by Barco NV (Kortrijk, BE). The FDA issued a Cleared decision on October 2, 2026 after a review of 79 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Barco NV devices

FDA 510(k) Submission Details - K262412

510(k) Number K262412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2026
Decision Date October 02, 2026
Days to Decision 79 days
Submission Type Special
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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Modification to existing cleared device.

PGY Device Classification - Class 2, Special Controls

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 137
Devices cleared under the same product code (PGY) and FDA review panel - the closest regulatory comparables to K262412.
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