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NIO 2MP (MDNG-2121)

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

510(k) K091172 Product code LLZ

Overview

The NIO 2MP (MDNG-2121) is a 2 MegaPixel diagnostic grayscale display system used for radiology imaging. This medical monitor is designed for diagnostic purposes, providing high-quality grayscale visualization for medical professionals.

The device is supplied as a standalone monitor system and is intended for use in diagnostic radiology settings. It is a reusable display system that requires appropriate storage conditions. The NIO 2MP (MDNG-2121) has received FDA 510(k) clearance with product code LLZ and was reviewed by the Radiology Advisory Committee.

Summary written by AI from registry data, 28 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 NumberK091172 Date5 May 2009ClearedStatusActive

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
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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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See all devices from Barco N.V. →

Questions

  • What is the NIO 2MP (MDNG-2121) display system used for?

    The NIO 2MP (MDNG-2121) is a diagnostic grayscale display system specifically designed for radiology imaging. It provides high-quality grayscale visualization for medical professionals in diagnostic radiology settings.

  • How is the NIO 2MP display system supplied and is it reusable?

    The device is supplied as a standalone monitor system and is designed for reuse. It requires appropriate storage conditions to maintain its functionality and diagnostic capabilities over time.

  • What regulatory approvals does the NIO 2MP display system have?

    The NIO 2MP (MDNG-2121) has received FDA 510(k) clearance with product code LLZ. It was reviewed by the Radiology Advisory Committee and determined to be substantially equivalent to predicate devices.

  • What are the key specifications of the NIO 2MP display system?

    The NIO 2MP (MDNG-2121) is a 2 MegaPixel diagnostic grayscale display system. It was manufactured by Barco N.V. and received FDA clearance on May 5, 2009, with K number K091172.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K091172 24 fields · synced 22 Oct 2026