Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630)— 510(k) K262412

Name: FDA 510(k) clearance K262412
Creator: U.S. Food and Drug Administration
Published: 2026-10-02

Substantially Equivalent

Barco NV

FDA 510(k) clearance K262412 for Coronis Fusion 4MP (MDCC-4630); Coronis Fusion 6MP (MDCC-6630), Substantially Equivalent on 2026-10-02. Applicant: Barco NV. Device class: 2.

Clearance details

Applicant: Barco NV
Product code: Code PGY
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-07-15
Decision date: 2026-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Kortrijk, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code PGY

view all

K262985 — Medical Monitor (32MD08WC)2026-10-02
K262783 — RadiForce MX247W2026-09-01
K261213 — Medical Monitor (40HT513D)2026-06-12
K252780 — LCD Monitor (CL1902A, CL2103F)2025-12-19
K253242 — LCD Monitor (C1216W, C822W, C821W)2025-10-29

Data sourced from openFDA. This site is unofficial and independent of the FDA.