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Coronis Fusion 4MP LED Display

by Barco N.V. United States 510(k)

510(k) K143157 Product code PGY

Overview

The Coronis Fusion 4MP LED Display is a diagnostic radiology display system designed for high-resolution medical imaging. It functions as a PACS (Picture Archiving and Communication System) monitor, providing radiologists with a 30-inch color LCD capable of seamless dual-head or wide-screen viewing for enhanced diagnostic flexibility.

This device is supplied as a reusable, non-sterile medical display and is intended for use in radiology settings. It operates under FDA 510(k) clearance (K143157) as a Class II diagnostic radiology display, adhering to regulatory standards for imaging equipment. The model number MDCC-4430 is included for identification, and its design supports productivity in diagnostic imaging workflows.

Summary written by AI from registry data, 19 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK143157 Date12 Nov 2014ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

510(k) · synced 6 Oct 2026

Full name
Coronis Fusion 4MP LED
510(k) Number
FDA Product Code
PGY
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Coronis Fusion 4MP LED primarily used for in a clinical setting?

    The Coronis Fusion 4MP LED is designed as a diagnostic radiology display system for high-resolution medical imaging, functioning as a PACS (Picture Archiving and Communication System) monitor. It enables radiologists to view medical images on a 30-inch color LCD with options for seamless dual-head or wide-screen configurations, improving diagnostic flexibility and workflow efficiency in radiology departments.

  • Is the Coronis Fusion 4MP LED intended for single-use or reusable applications?

    The Coronis Fusion 4MP LED is reusable and non-sterile, meaning it is meant for repeated use in radiology environments. Since it is not classified as a sterile device, it does not require single-use disposal and is maintained as part of the imaging equipment infrastructure.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Coronis Fusion 4MP LED received FDA 510(k) clearance under the classification of Class II diagnostic radiology display, with the K-number K143157. The submission was reviewed by the Radiology (RA) Advisory Committee and granted a Substantially Equivalent (SESE) decision, confirming compliance with regulatory standards for imaging displays.

  • What model number identifies this specific device, and how does it support its intended use?

    The model number for the Coronis Fusion 4MP LED is MDCC-4430, which serves as a unique identifier for this 30-inch high-resolution LED display. Its design supports dual-head or wide-screen viewing, enhancing productivity in diagnostic imaging workflows by providing clear, detailed visuals for radiologists.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K143157 24 fields · synced 6 Oct 2026