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BarcoMed 5MP2

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

510(k) K000016 Product code LLZ

Overview

The BarcoMed 5MP2 is a dual-head medical display controller designed for radiology applications. Classified under product code LLZ, it serves as a graphics controller for high-resolution medical imaging systems, ensuring precise visual output for diagnostic and procedural use. Its 5-megapixel resolution supports detailed imaging requirements in X-ray and other radiologic modalities. The device integrates with display systems to enhance diagnostic accuracy and workflow efficiency in clinical settings.

The BarcoMed 5MP2 is supplied as a reusable hardware component, intended for integration into radiology workstations. It operates in non-sterile environments and does not require single-use compliance. The device is MRI-unsafe and must be positioned outside the MRI scanning room or area. Authorized under FDA 510(k) clearance (K000016), it adheres to regulatory standards for medical imaging equipment. Storage and handling follow standard electronic device protocols to maintain functionality and performance.

Summary written by AI from registry data, 1 Oct 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 NumberK000016 Date14 Mar 2000ClearedStatusActive

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 BarcoMed 5MP2 used for?

    The BarcoMed 5MP2 is a dual-head medical display controller designed for radiology applications, serving as a graphics controller for high-resolution medical imaging systems to ensure precise visual output for diagnostic and procedural use.

  • Is the BarcoMed 5MP2 a single-use device?

    No, the BarcoMed 5MP2 is supplied as a reusable hardware component intended for integration into radiology workstations and operates in non-sterile environments without requiring single-use compliance.

  • What are the key specifications of the BarcoMed 5MP2?

    The BarcoMed 5MP2 features a 5-megapixel resolution and is classified under product code LLZ. It is MRI-unsafe and must be positioned outside MRI scanning areas. It has FDA 510(k) clearance (K000016) and follows standard electronic device protocols for storage and handling.

  • How is the BarcoMed 5MP2 integrated into clinical settings?

    The device integrates with display systems to enhance diagnostic accuracy and workflow efficiency in clinical settings, particularly for detailed imaging requirements in X-ray and other radiologic modalities.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K000016 24 fields · synced 22 Oct 2026