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Coronis 5MP

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

510(k) K111990 Product code LLZ

Overview

The Coronis 5MP is a medical display device used in radiology for the presentation of grayscale medical images. It features a 5-megapixel resolution and 10-bit architecture, enabling accurate image representation with 1024 simultaneous shades of gray from a palette of 4096.

The device is supplied as a system for installation and use in medical imaging environments. It is authorized under FDA 510(k) clearance (K111990) and is intended for use in radiology settings as part of a medical imaging workflow. No claims are made regarding sterility, single-use status, MRI safety, or storage conditions in the provided data.

Summary written by AI from registry data, 25 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 · Traditional NumberK111990 Date17 Oct 2011ClearedStatusActive

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 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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 is the Coronis 5MP used for?

    The Coronis 5MP is a medical display device used in radiology for the presentation of grayscale medical images, enabling accurate image representation with 1024 simultaneous shades of gray from a palette of 4096 due to its 5-megapixel resolution and 10-bit architecture.

  • How is the Coronis 5MP supplied and installed?

    The Coronis 5MP is supplied as a complete system for installation and use in medical imaging environments, intended to be integrated into radiology workflows as part of a medical imaging setup, though specific installation components are not detailed in the provided data.

  • Is the Coronis 5MP a sterile or single-use device?

    No claims are made regarding sterility or single-use status for the Coronis 5MP in the provided data; it is a reusable medical display device designed for ongoing use in radiology settings, not intended for sterile fields or disposable application.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K111990 24 fields · synced 22 Oct 2026