Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9613188

FEI Number

3004455125

Entity Name

BARCO N.V.

City/State/Country

KORTRIJK West-Vlaanderen, BE

Establishment Address

35 PRESIDENT KENNEDYPARK, KORTRIJK West-Vlaanderen 8500, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BARCO NV (Owner Number: 9031117)

Owner / Operator Contact Address

Beneluxpark 21, Kortrijk, BE-VWV 8500, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K122167

PMA Number

N/A

All Registered Proprietary Names

Coronis uniti Uniti MDMC-12133 MDMC-12133 Coronis Uniti NMS Nexxis MNA MNA-110 Nexxis Nexxis NMS MNA-240 MNA-120 Nexxis OR MNA-420 MNA-440 MDNC-2123 Nio Color 2MP MDSC-8258 MDSC-2226 MDSC-2232 MDSC-8232 AMM215WTD MDSC-8255 AMM215WTTP MDSC-8358 MDSC-2326 AMM240ED MDSC-2324 MDSC-8231 MDSC-8331 MDSC-8427 MDFC-8232 MDSC-8532 MDSC-8527 Vividimage®32 4K DL Precise MNA-110 MNA-120 NMS Network Management Software Nexxis OR MNC-180 MNA-240 MDNC-6121 MDNG-6221 MDNC-12130 Nio Fusion 12MP MDPC-8127 MDNC-3421 Coronis OneLook MDMC-32133 MDEC-2523 MDCC-6530 Coronis Fusion 6MP Coronis Fusion 4MP Intuitive Workflow Tools (IWT) MDCC-4430 MDNC-8132 Nio Color 8MP QAWeb Enterprise MDCG-5221 Coronis 5MP MDNG-5221 Nio 5MP LED Nexxis Nexxis OR Nexxis MNA Nexxis NMS MNA-110 MNA-120 MNA-240

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2015-10-27
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2015-03-31
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2018-02-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-09-08
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2007-01-24
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-11-21
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2017-06-15
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-04-07
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2020-11-19
PSY	Whole Slide Imaging System	Pathology	Class 2	864.3700	2021-04-23
PZZ	Digital Pathology Display	Pathology	Class 2	864.3700	2021-04-23
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-04-07
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2024-09-23
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-09-17
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-12-12
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	2018-10-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2014-05-09
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2013-07-17

Official Correspondent

No official correspondent registered.

US Agent Details

Roxana Allen Business: Barco Inc. Email: roxana.allen@barco.com Phone: (678) 2008674

Related Public Records

Same Entity

BARCO NV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004578804	Barco, Inc	DULUTH, GA, US
3024689474	Barco Inc Portland	Portland, OR, US
3024137003	Barco (Suzhou) Healthcare Technology Co., Ltd.	Suzhou Jiangsu, CN
1000181154	BARCO S.R.L.	Saronno Varese, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
K180534	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue GuardianSoftware	2018-07-16
K161767	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue GuardianSoftware	2017-01-27
K212208	Philips Medizin Systeme Boeblingen GmbH	Philips IntelliVue GuardianSoftware (Rev. E.0X)	2021-09-30
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9613188. Last updated year: 2026. Please use registration number 9613188 when referencing this establishment in official correspondence.