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Coronis 5MP Medical Flat Panel Display System

by Barco NV Barcoview EUDAMED510(k)

Active European Union and United States

510(k) K042221

Overview

The Coronis 5MP Medical Flat Panel Display System is a high-resolution medical display device designed for visualizing digital medical images. Classified as a diagnostic imaging display system, it transforms digital image data into high-definition visual output for clinical assessment, supporting applications such as digital mammography.

This system is intended for use in clinical settings by trained medical practitioners to facilitate diagnostic decision-making. Supplied as a reusable device, it requires no sterilization and is not MRI-safe. Authorized under FDA 510(k) clearance and MDR compliance, it operates as a standalone display solution for radiology workflows.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK042221 Date30 Dec 2004ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · 510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical applications is the Coronis 5MP Medical Flat Panel Display System primarily designed for?

    The Coronis 5MP is specifically designed for visualizing digital medical images in radiology workflows, with a focus on high-resolution display for diagnostic assessment. Its primary application is supporting digital mammography, where clear and precise imaging is critical for accurate diagnosis by trained medical practitioners.

  • Is the Coronis 5MP Medical Flat Panel Display System intended for single-use or reusable in clinical settings?

    The Coronis 5MP is supplied as a reusable device and does not require sterilization, making it suitable for long-term use in clinical environments where multiple diagnostic assessments are performed. This design reduces operational costs and waste compared to single-use alternatives.

  • What regulatory pathways has the Coronis 5MP Medical Flat Panel Display System followed for market authorization?

    The device has been authorized through the FDA’s 510(k) clearance process, specifically under a Traditional review pathway, and is also compliant with the EU’s Medical Device Regulation (MDR). These pathways confirm its substantial equivalence to a previously cleared device and adherence to safety and performance standards.

  • How is the Coronis 5MP Medical Flat Panel Display System intended to integrate into a radiology department’s workflow?

    As a standalone display solution, the Coronis 5MP is engineered to enhance diagnostic decision-making by providing high-definition visual output for digital medical images. It is intended for use by trained medical practitioners in clinical settings, supporting applications like digital mammography where precise imaging is essential for accurate assessments.