Barco N.V.
KORTRIJK West-Vlaanderen, BE
BARCO N.V. appears in FDA device records in KORTRIJK West-Vlaanderen, BE. FDA records list 53 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Barco N.V. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Barcoview510(k), recall
510(k) clearance history
Showing 50 of 53FDA records hold 53 510(k) clearances for Barco N.V. between 2005 and 2024. The busiest year on record is 2005, with 10. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 10 |
| 2006 | 6 |
| 2007 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 1 |
| 2013 | 4 |
| 2014 | 5 |
| 2015 | 2 |
| 2016 | 1 |
| 2017 | 6 |
| 2018 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 2 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243307 | LCD Monitor (MDEC-2523) | GCJ | Substantially Equivalent | |
| K242008 | Coronis OneLook | PGY | Substantially Equivalent | |
| K233693 | Nio Color 8MP (MDNC-8132) | PGY | Substantially Equivalent | |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | PGY | Substantially Equivalent | |
| K213957 | Demetra Dermatoscope BDEM-01 | PSN | Substantially Equivalent | |
| K203364 | MDPC-8127 | PSY | Substantially Equivalent | |
| K201408 | Demetra Analytics Toolkit | PSN | Substantially Equivalent | |
| K203106 | Nio Fusion 12MP (MDNC-12130) | PGY | Substantially Equivalent | |
| K192829 | Demetra BDEM-01 Dermatoscope | PSN | Substantially Equivalent | |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | PGY | Substantially Equivalent | |
| K173381 | Nexxis OR | DXJ | Substantially Equivalent | |
| K172922 | MMPC-4127F1 | PZZ | Substantially Equivalent | |
| K171812 | Nio Color 2MP (MDNC-2123) | PGY | Substantially Equivalent | |
| K170537 | Nexxis OR, Nexxis | DXJ | Substantially Equivalent | |
| K170837 | Nio Color 3MP (MDNC-3421) | PGY | Substantially Equivalent | |
| K170476 | Nio Color 5.8MP (MDNC-6121) | PGY | Substantially Equivalent | |
| K161880 | NIVR58-T kit | DXJ | Substantially Equivalent | |
| K161229 | Mammo Tomosynthesis (MDMG-5221) | PGY | Substantially Equivalent | |
| K151505 | Coronis Uniti | PGY | Substantially Equivalent | |
| K150821 | MDNG-3220 (Nio 3MP LED) | PGY | Substantially Equivalent | |
| K133994 | SIVR56-T KIT | DXJ | Substantially Equivalent | |
| K143157 | Coronis Fusion 4MP LED | PGY | Substantially Equivalent | |
| K141428 | MDMC-12133 | PGY | Substantially Equivalent | |
| K133984 | CORONIS 5MP | LLZ | Substantially Equivalent | |
| K133663 | NIO COLOR 2MP | LLZ | Substantially Equivalent | |
| K131295 | NIO COLOR 3MP LED | LLZ | Substantially Equivalent | |
| K131246 | CORONIS 3MP | LLZ | Substantially Equivalent | |
| K122167 | NEXXIS OR | DXJ | Substantially Equivalent | |
| K130103 | CORONIS FUSION 6MP | LLZ | Substantially Equivalent | |
| K121788 | NIO 5MP | LLZ | Substantially Equivalent | |
| K111990 | CORONIS 5MP | LLZ | Substantially Equivalent | |
| K111989 | CORONIS FUSION 4MP DL | LLZ | Substantially Equivalent | |
| K111991 | NIO COLOR 2MP | LLZ | Substantially Equivalent | |
| K093197 | CORONIS FUSION 10MP, MODEL MDCG-10130 | LLZ | Substantially Equivalent | |
| K091274 | CORONIS 5MP HD, MODEL MDMG 5121 | LLZ | Substantially Equivalent | |
| K090732 | NIO COLOR 3MP AND MDNC-3121 | LLZ | Substantially Equivalent | |
| K062621 | NIO 5MP-21 AND MDNG-5121 CB | LLZ | Substantially Equivalent | |
| K062905 | NIO FUSION 4MP; MDNC 4130 | LLZ | Substantially Equivalent | |
| K062131 | NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB | LLZ | Substantially Equivalent | |
| K061928 | CORONIS COLOR 2MP AND MDCC 2121 | LLZ | Substantially Equivalent | |
| K061927 | CORONIS COLOR 3MP AND MDCC 3120-DL | LLZ | Substantially Equivalent | |
| K061924 | CORONIS 3MP AND MDCG 3120-CB | LLZ | Substantially Equivalent | |
| K061926 | CORONIS 2MP AND MDCG 2121 - CB | LLZ | Substantially Equivalent | |
| K052958 | COLOR NIO 2MP, E-2320 C | LLZ | Substantially Equivalent | |
| K052529 | E-2320 PA S | LLZ | Substantially Equivalent | |
| K052352 | COLOR CORONIS 2MP-21 AND MFCD 2321 | LLZ | Substantially Equivalent | |
| K052478 | MFCD 1219, MFCD 1219 TS | LLZ | Substantially Equivalent | |
| K052276 | NIO 2MP-20 AND E-2620 S | LLZ | Substantially Equivalent | |
| K052429 | CORONIS 3MP-21 AND MFGD 3621 | LLZ | Substantially Equivalent | |
| K052403 | CORONIS 2MP-21 AND MFGD 2621 | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9613188 | 3004455125 | BARCO N.V. | 35 PRESIDENT KENNEDYPARK, KORTRIJK West-Vlaanderen 8500 BE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KQMCamera, Surgical And Accessories
- PZZDigital Pathology Display
- DXJDisplay, Cathode-Ray Tube, Medical
- PGYDisplay, Diagnostic Radiology
- LHOInstrument, Quality-Assurance, Radiologic
- GCJLaparoscope, General & Plastic Surgery
- PSNLight Based Imaging
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- PSYWhole Slide Imaging System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1994-2025 | 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: MNA-640 DEC -H/K9306410, MNA-640 ENC -H/K9306420; components of the NexxisOR system | 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 | Class II | Open, Classified | |
| Z-2332-2024 | 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 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. | Class II | Completed | |
| Z-0979-2024 | 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. | Class II | Open, Classified | |
| Z-1172-2021 | 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. | Class II | Terminated | |
| Z-0527-2019 | 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. | Class II | Terminated | |
| Z-0276-2009 | 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 connectivity, the MDSC-2124 offers a versatile display solution for HD endoscopy cameras, room and boom cameras, ultrasound, PACS and patient information. | The front protective cover may loosen and completely fall off. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain