Company · BE
Barco N.V.
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2026. Name variants (Inc, Corp, punctuation) are merged.
61510(k) clearances (1 in 12 months)
5recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLZ | System, Image Processing, Radiological | 37 |
| PGY | Display, Diagnostic Radiology | 13 |
| DXJ | Display, Cathode-Ray Tube, Medical | 8 |
| PSN | Light Based Imaging | 3 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 |
| KQM | Camera, Surgical And Accessories | 1 |
| OWB | Interventional Fluoroscopic X-Ray System | 1 |
| PSY | Whole Slide Imaging System | 1 |
| PZZ | Digital Pathology Display | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 30, 2026 | K261469 | Nexxis 2;Nexxis OR 2;NMS 2;MNA-240;MNA-4x0 (Where x may be any numeric character). Barco N.V., BE | DXJ |
| Dec 13, 2024 | K243307 | LCD Monitor (MDEC-2523) Barco N.V., BE | GCJ |
| Aug 2, 2024 | K242008 | Coronis OneLook Barco N.V., BE | PGY |
| Dec 11, 2023 | K233693 | Nio Color 8MP (MDNC-8132) Barco N.V., BE | PGY |
| Mar 21, 2023 | K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) Barco N.V., BE | PGY |
| Mar 11, 2022 | K213957 | Demetra Dermatoscope BDEM-01 Barco N.V., BE | PSN |
| Apr 15, 2021 | K203364 | MDPC-8127 Barco N.V., BE | PSY |
| Feb 18, 2021 | K201408 | Demetra Analytics Toolkit Barco N.V., BE | PSN |
| Nov 10, 2020 | K203106 | Nio Fusion 12MP (MDNC-12130) Barco N.V., BE | PGY |
| Dec 13, 2019 | K192829 | Demetra BDEM-01 Dermatoscope Barco N.V., BE | PSN |
| Sep 6, 2019 | K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) Barco N.V., BE | PGY |
| Feb 22, 2018 | K173381 | Nexxis OR Barco N.V., BE | DXJ |
| Dec 21, 2017 | K172922 | MMPC-4127F1 Barco N.V., BE | PZZ |
| Jul 19, 2017 | K171812 | Nio Color 2MP (MDNC-2123) Barco N.V., BE | PGY |
| Apr 21, 2017 | K170537 | Nexxis OR, Nexxis Barco N.V., BE | DXJ |
| Apr 5, 2017 | K170837 | Nio Color 3MP (MDNC-3421) Barco N.V., BE | PGY |
| Mar 28, 2017 | K170476 | Nio Color 5.8MP (MDNC-6121) Barco N.V., BE | PGY |
| Mar 14, 2017 | K161880 | NIVR58-T kit Barco N.V., BE | DXJ |
| May 18, 2016 | K161229 | Mammo Tomosynthesis (MDMG-5221) Barco N.V., BE | PGY |
| Jul 17, 2015 | K151505 | Coronis Uniti Barco N.V., BE | PGY |
| Dec 1, 2014 | K133994 | SIVR56-T KIT Barco N.V., BE | DXJ |
| Nov 12, 2014 | K143157 | Coronis Fusion 4MP LED Barco N.V., BE | PGY |
| Jun 27, 2014 | K141428 | MDMC-12133 Barco N.V., BE | PGY |
| Mar 28, 2014 | K133984 | CORONIS 5MP Barco N.V., BE | LLZ |
| Mar 25, 2014 | K133663 | NIO COLOR 2MP Barco N.V., BE | LLZ |
| May 29, 2013 | K131295 | NIO COLOR 3MP LED Barco N.V., BE | LLZ |
| May 24, 2013 | K131246 | CORONIS 3MP Barco N.V., BE | LLZ |
| Apr 22, 2013 | K122167 | NEXXIS OR Barco N.V., BE | DXJ |
| Feb 8, 2013 | K130103 | CORONIS FUSION 6MP Barco N.V., BE | LLZ |
| Jul 23, 2012 | K121788 | NIO 5MP Barco N.V., BE | LLZ |
| Oct 17, 2011 | K111990 | CORONIS 5MP Barco N.V., BE | LLZ |
| Sep 22, 2011 | K111989 | CORONIS FUSION 4MP DL Barco N.V., BE | LLZ |
| Aug 11, 2011 | K111991 | NIO COLOR 2MP Barco N.V., BE | LLZ |
| Mar 4, 2011 | K103792 | BARCO MAMMO TOMOSYNTHESIS Barco N.V., BE | LLZ |
| Jun 23, 2010 | K093197 | CORONIS FUSION 10MP, MODEL MDCG-10130 Barco N.V., BE | LLZ |
| Jul 14, 2009 | K091274 | CORONIS 5MP HD, MODEL MDMG 5121 Barco N.V., BE | LLZ |
| May 5, 2009 | K091172 | NIO 2MP (MDNG-2121) Barco N.V., BE | LLZ |
| Apr 22, 2009 | K090603 | BARCO 5MP MAMMO, MODEL MDMG-5221 Barco N.V. | LLZ |
| Apr 20, 2009 | K090732 | NIO COLOR 3MP AND MDNC-3121 Barco N.V., BE | LLZ |
| Apr 28, 2004 | K040365 | COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. | LLZ |
| Apr 12, 2004 | K040158 | MFCD 2320 Barco N.V. | LLZ |
| Mar 17, 2004 | K040039 | NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM Barco N.V. | LLZ |
| Jan 17, 2003 | K023533 | BARCO MEDIS 5MP2 AURA Barco N.V. | LLZ |
| Dec 23, 2002 | K023341 | CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. | LLZ |
| Dec 23, 2002 | K023340 | CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. | LLZ |
| Dec 23, 2002 | K023339 | IMAGETILE Barco N.V. | LLZ |
| Dec 23, 2002 | K023322 | CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM Barco N.V. | LLZ |
| Dec 13, 2002 | K022773 | BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM Barco N.V. | LLZ |
| Jul 12, 2002 | K020073 | MEDICAL ADMINISTRATOR Barco N.V. | LLZ |
| Apr 4, 2002 | K020058 | MEDICAL LE Barco N.V. | LLZ |
Newest 50 of 61.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2025 | Barco N.V. 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/K Open, Classified |
DXJ | K173381 |
| Jul 11, 2024 | Barco N.V. MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display Completed |
DXJ | K173381 |
| Feb 2, 2024 | Barco N.V. Barco MDSC-8527 NXF, Part Number K9352421 Open, Classified |
KQM | None listed |
| Jan 22, 2021 | Barco N.V. Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY Terminated |
PGY | K170837 |
| Mar 30, 2017 | Barco N.V. 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- Terminated |
OWB | None listed |