Data / Medical devices / Belgium / Barco N.V.

Barco N.V.: FDA-registered device maker in KORTRIJK West-Vlaanderen, Belgium, 19 510(k) clearances

Name: Barco N.V. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Barco N.V. is registered with the FDA (registration 9613188) in KORTRIJK West-Vlaanderen, Belgium. It lists 9 device types. The FDA files 19 510(k) clearances under its listings, the newest dated September 30, 2026. 6 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9613188
FEI number: 3004455125
Address: 35 President Kennedypark, KORTRIJK West-Vlaanderen, Belgium, 8500
Owner or operator: BARCO NV (9031117)
Roles: Exporter to the US, Manufacturer, Specification developer
First device listed: August 13, 2001
Registered through: 2027
Brand names listed: AMM215WTD, AMM215WTTP, AMM240ED, Coronis 5MP, Coronis Fusion 4MP, Coronis Fusion 6MP, Coronis OneLook, Coronis Uniti and more

Devices it lists

Device	Product code	Class	Role	Source
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Digital Pathology Display	PZZ	2	Manufacturer	accessdata.fda.gov
Display, Cathode-Ray Tube, Medical	DXJ	2	Manufacturer	accessdata.fda.gov
Display, Diagnostic Radiology	PGY	2	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Exporter to the US, Manufacturer, Specification developer	accessdata.fda.gov
Whole Slide Imaging System	PSY	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 30, 2026	K261469	Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character).	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
December 13, 2024	K243307	LCD Monitor (MDEC-2523)	GCJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
August 2, 2024	K242008	Coronis OneLook	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
December 11, 2023	K233693	Nio Color 8MP (MDNC-8132)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
March 21, 2023	K230520	Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
April 15, 2021	K203364	MDPC-8127	PSY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
April 9, 2021	K202084	DeepLook PRECISE	LLZ	Substantially Equivalent	Deeplook, Inc.	accessdata.fda.gov
November 10, 2020	K203106	Nio Fusion 12MP (MDNC-12130)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
September 6, 2019	K191845	Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
February 22, 2018	K173381	Nexxis OR	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
July 19, 2017	K171812	Nio Color 2MP (MDNC-2123)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
April 21, 2017	K170537	Nexxis OR, Nexxis	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
April 5, 2017	K170837	Nio Color 3MP (MDNC-3421)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
March 28, 2017	K170476	Nio Color 5.8MP (MDNC-6121)	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
July 17, 2015	K151505	Coronis Uniti	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
June 27, 2014	K141428	MDMC-12133	PGY	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
March 28, 2014	K133984	CORONIS 5MP	LLZ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
March 25, 2014	K133663	NIO COLOR 2MP	LLZ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov
April 22, 2013	K122167	NEXXIS OR	DXJ	Substantially Equivalent	Barco N.V.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 9, 2025	96885	Class II	Ongoing	Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA-440 ENC -H/K9303300, MNA-440 DEC -H V2/K9303311; MNA-620: MNA-620 DEC -H/K9306210, MNA-620 ENC -H/K9306220; and MNA-640:	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, mi	accessdata.fda.gov
April 24, 2024	94731	Class II	Completed	MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display	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	accessdata.fda.gov
December 20, 2023	93712	Class II	Ongoing	Barco MDSC-8527 NXF, Part Number K9352421	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.	accessdata.fda.gov
January 22, 2021	87288	Class II	Terminated	Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY	A number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass DICOM acceptance tests.	accessdata.fda.gov
March 30, 2017	81239	Class II	Terminated	Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The product is an optional kit, intended to be attached in front of the LCD panel of a review display (MDRC-1119).	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.	accessdata.fda.gov
September 9, 2008	50068	Not yet classified	Terminated	Barco Surgical Display, Model MDSC-2124 The 24-inch MDSC-2124 is a near-patient surgical display that uses widescreen (16:10) LCD technology featuring full High Definition resolution (1920 x 1200). Featuring broad input	The front protective cover may loosen and completely fall off.	accessdata.fda.gov

Compare with other makers

Updated September 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.