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Barco N.V.

US Last updated 23 May 2026

Devices
56
Registries
FDA 510(k)FDA
FDA recalls
52 ongoing

Catalogue56

Page 1 of 2

Showing 1-50 of 56

FDA recalls5

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2025

    • 9 May 2025 Z-1994-2025 Class II Ongoing Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not functioning reliably:audio, video and/or control signals might be interrupted or fall away, displays might switch to failover and back multiple times, devices/sources/sinks might not be discovered/available, might lead to delayed/prolonged procedures

  • 2024

    • 24 Apr 2024 Z-2332-2024 Class II Completed We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when connected to the ETH0 slot of either the MNA-6x0 ENC HDMI or MNA-4x0 ENC HDMI. In some instances, this connection may render the first HDMI channel inaccessible, making both the channel and the respective MNA ENC unit unusable. Additionally, readings from the module become unavailable when this issue arises. Similarly, when this Molex module is connected to the ETH0 slot of an MNA-620 ENC ANA, readings may also become inaccessible.

  • 2023

    • 20 Dec 2023 Z-0979-2024 Class II Ongoing Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.

  • 2021

    • 22 Jan 2021 Z-1172-2021 Class II Terminated A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.

  • 2017

    • 30 Mar 2017 Z-0527-2019 Class II Terminated If metal strips are removed and re-applied to another display, there is potential for the metal strips to be deformed resulting in a smaller contact surface with the front cover magnet strips. There is a risk that the protective front cover could come loose and may fall down.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Barco N.V. KORTRIJK West-Vlaanderen · BE FEI 3004455125

What Barco N.V. makes

Barco N.V. manufactures medical imaging displays, including high-resolution LCD monitors (e.g., MDEC-2523), flat-panel display systems (e.g., Coronis 1MP, 2MP, 3MP, and 4MP/6MP LED variants like MDCC-4430 and MDCC-6530), and software for display calibration and consistency. Their portfolio also includes digital radiography tools like the ImageDesk and mammography-specific systems such as the Barco Mammo Tomosynthesis display. Additional products include workflow optimization tools (Intuitive Workflow Tools) and modular display solutions like ImageTile and NIO Color variants for enhanced diagnostic imaging environments.

The company’s devices are classified under Class II in the U.S. and are listed in the FDA 510(k) registry, reflecting their regulatory compliance for medical imaging displays and related software. Barco N.V. operates from the U.S., adhering to U.S. medical device regulations for these products.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Barco N.V. manufacture?

Barco N.V. specializes in medical imaging displays and related technology. Their portfolio includes high-resolution LCD monitors like the MDEC-2523, flat-panel display systems such as the Coronis 1MP, 2MP, 3MP, and 4MP/6MP LED variants (e.g., MDCC-4430 and MDCC-6530), and software for display calibration and consistency. They also produce specialized tools for digital radiography, including the ImageDesk and Barco Mammo Tomosynthesis system for mammography, as well as workflow optimization tools like Intuitive Workflow Tools and modular display solutions like ImageTile and NIO Color variants.

Where is Barco N.V. based, and how does this affect its medical devices?

Barco N.V. is based in the United States, which means its medical devices are designed and marketed in compliance with U.S. regulatory requirements. This includes adherence to the classification system and registration processes specific to the U.S., such as the FDA’s 510(k) pathway for Class II devices, ensuring their products meet the necessary standards for safety and performance in the U.S. market.

Which regulatory registries list Barco N.V.’s medical devices?

Barco N.V.’s medical devices are listed in the FDA 510(k) registry, which is a database of Class II medical devices that have undergone the 510(k) premarket notification process. This registry confirms that the devices have been evaluated for substantial equivalence to a predicate device and comply with applicable U.S. regulations before being marketed.

How are Barco N.V.’s medical devices classified in the U.S.?

Barco N.V.’s medical devices are classified under Class II in the U.S. This classification applies to devices that pose moderate risk and require special controls to ensure their safety and effectiveness. Class II devices typically require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet regulatory standards before commercial distribution.

AI-generated from registry data and not verified by a human reviewer.

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