Barco N.V.
Medical device manufacturer in Kortrijk, Belg.
60510(k) clearances
0PMA approvals
5recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K243307 | LCD Monitor (MDEC-2523)GCJ · Traditional | 12/13/2024SE |
| K242008 | Coronis OneLookPGY · Special | 08/02/2024SE |
| K233693 | Nio Color 8MP (MDNC-8132)PGY · Special | 12/11/2023SE |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)PGY · Special | 03/21/2023SE |
| K213957 | Demetra Dermatoscope BDEM-01PSN · Special | 03/11/2022SE |
| K203364 | MDPC-8127PSY · Traditional | 04/15/2021SE |
| K201408 | Demetra Analytics ToolkitPSN · Traditional | 02/18/2021SE |
| K203106 | Nio Fusion 12MP (MDNC-12130)PGY · Special | 11/10/2020SE |
| K192829 | Demetra BDEM-01 DermatoscopePSN · Traditional | 12/13/2019SE |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools…PGY · Traditional | 09/06/2019SE |
| K173381 | Nexxis ORDXJ · Special | 02/22/2018SE |
| K172922 | MMPC-4127F1PZZ · Traditional | 12/21/2017SE |
| K171812 | Nio Color 2MP (MDNC-2123)PGY · Special | 07/19/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | 04/21/2017SE |
| K170837 | Nio Color 3MP (MDNC-3421)PGY · Special | 04/05/2017SE |
| K170476 | Nio Color 5.8MP (MDNC-6121)PGY · Special | 03/28/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | 03/14/2017SE |
| K161229 | Mammo Tomosynthesis (MDMG-5221)PGY · Special | 05/18/2016SE |
| K151505 | Coronis UnitiPGY · Traditional | 07/17/2015SE |
| K133994 | SIVR56-T KitDXJ · Traditional | 12/01/2014SE |
| K143157 | Coronis Fusion 4MP LEDPGY · Special | 11/12/2014SE |
| K141428 | MDMC-12133PGY · Traditional | 06/27/2014SE |
| K133984 | Coronis 5MPLLZ · Traditional | 03/28/2014SE |
| K133663 | Nio Color 2MPLLZ · Traditional | 03/25/2014SE |
| K131295 | Nio Color 3MP LEDLLZ · Special | 05/29/2013SE |
| K131246 | Coronis 3MPLLZ · Special | 05/24/2013SE |
| K122167 | Nexxis orDXJ · Traditional | 04/22/2013SE |
| K130103 | Coronis Fusion 6MPLLZ · Special | 02/08/2013SE |
| K121788 | Nio 5MPLLZ · Traditional | 07/23/2012SE |
| K111990 | Coronis 5MPLLZ · Traditional | 10/17/2011SE |
| K111989 | Coronis Fusion 4MP DLLLZ · Special | 09/22/2011SE |
| K111991 | Nio Color 2MPLLZ · Traditional | 08/11/2011SE |
| K103792 | Barco Mammo TomosynthesisLLZ · Traditional | 03/04/2011SE |
| K093197 | Coronis Fusion 10MP, Model MDCG-10130LLZ · Traditional | 06/23/2010SE |
| K091274 | Coronis 5MP HD, Model MDMG 5121LLZ · Special | 07/14/2009SE |
| K091172 | Nio 2MP (MDNG-2121)LLZ · Traditional | 05/05/2009SE |
| K090603 | Barco 5MP Mammo, Model MDMG-5221LLZ · Traditional | 04/22/2009SE |
| K090732 | Nio Color 3MP and MDNC-3121LLZ · Special | 04/20/2009SE |
| K040365 | Color Coronis 2MP Medical Flat Panel Display SystemLLZ · Traditional | 04/28/2004SE |
| K040158 | MFCD 2320LLZ · Traditional | 04/12/2004SE |
| K040039 | Nio 2MP Medical Grayscale Display SystemLLZ · Traditional | 03/17/2004SE |
| K023533 | Barco Medis 5MP2 AuraLLZ · Traditional | 01/17/2003SE |
| K023341 | Cornis 5MP Medical Flat Panel Display SystemLLZ · Traditional | 12/23/2002SE |
| K023340 | Coronis 1MP Medical Flat Panel Display SystemLLZ · Traditional | 12/23/2002SE |
| K023339 | ImagetileLLZ · Traditional | 12/23/2002SE |
| K023322 | Coronis 2MP Medical Flat Panel Display SystemLLZ · Traditional | 12/23/2002SE |
| K022773 | Barco Medis 2MP1NT Medical Diagnostic Display SystemLLZ · Traditional | 12/13/2002SE |
| K020073 | Medical AdministratorLLZ · Traditional | 07/12/2002SE |
| K020058 | Medical LeLLZ · Traditional | 04/04/2002SE |
| K020061 | ImagedeskLLZ · Traditional | 04/03/2002SE |
| K020059 | MFCD 118ILLZ · Traditional | 04/03/2002SE |
| K013922 | Coronis 3MP Medicl Flat Panel Display SystemLLZ · Traditional | 01/28/2002SE |
| K000293 | Barco MGD 221 2 Megapixel Diagnostic DisplayLLZ · Traditional | 03/29/2000SE |
| K000292 | Barco MWD 321 Plus Medical Workstation DisplayLLZ · Traditional | 03/29/2000SE |
| K000294 | MFCD 120LLZ · Traditional | 03/27/2000SE |
| K000291 | MFCD 118LLZ · Traditional | 03/27/2000SE |
| K000016 | Barcomed 5MP2LLZ · Traditional | 03/14/2000SE |
| K000014 | Barcomed 5MP1HLLZ · Traditional | 03/14/2000SE |
| K000015 | Barcomed 2MP2LLZ · Traditional | 02/04/2000SE |
| K982690 | Barco Medical Display Conformity and Consistency SoftwareLLZ · Traditional | 10/06/1998SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1994-2025 Class II | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331…Cathode ray tube display system encoders and decoders have same MAC address; new system setup with two or… | 05/09/2025Open, Classified |
| Z-2332-2024 Class II | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayWe have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050) when… | 04/24/2024Completed |
| Z-0979-2024 Class II | Barco MDSC-8527 NXF, Part Number K9352421Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx… | 12/20/2023Open, Classified |
| Z-1172-2021 Class II | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGYA number of MDNC-3421 displays were shipped while not being DICOM-compliant. These displays will not pass… | 01/22/2021Terminated |
| Z-0527-2019 Class II | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product…If metal strips are removed and re-applied to another display, there is potential for the metal strips to be… | 03/30/2017Terminated |