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Barco Medical Display Conformity and Consistency Software

by Barco N.V. FDA registration: Belgium 510(k)

510(k) K982690 Product code LLZ

Overview

The Barco Medical Display Conformity and Consistency Software is a device intended to be used as a tool in displaying and viewing digital images for review and analysis. It is designed to ensure conformity and consistency in medical image display.

This software is supplied by Barco N.V. and is a Class II device that received FDA 510(k) clearance in 1998. It is used in radiology settings and is regulated under product code LLZ. The device is not specified as single-use or reusable, and no MRI safety information is provided.

Summary written by AI from registry data, 23 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 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982690 Date6 Oct 1998ClearedStatusActive

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

Other devices from Barco N.V.

See all devices from Barco N.V. →

Questions

  • What is the Barco Medical Display Conformity and Consistency Software used for?

    This software is designed as a tool for displaying and viewing digital medical images for review and analysis, ensuring conformity and consistency in medical image display within radiology settings.

  • How is the Barco Medical Display Conformity and Consistency Software supplied?

    The software is supplied by Barco N.V. and is a Class II medical device that received FDA 510(k) clearance in 1998, regulated under product code LLZ.

  • Is the Barco Medical Display Conformity and Consistency Software single-use or reusable?

    The device is not specified as single-use or reusable in the provided information, so its usage status would need to be confirmed directly with the manufacturer.

  • What regulatory route has the Barco Medical Display Conformity and Consistency Software taken?

    The software received FDA 510(k) clearance in 1998, with a decision code of SESE (Substantially Equivalent), and was reviewed by the Radiology Advisory Committee.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K982690 24 fields · synced 22 Oct 2026