Barco N.V.
FDA Regulatory Profile
Barco N.V. appears in FDA public data with 5 recalls, 60 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1994-2025, Class II) was initiated on May 9, 2025. Its most recent 510(k) clearance was granted on December 13, 2024.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 60
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1994-2025 | Class II | Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNA | May 9, 2025 |
| Z-2332-2024 | Class II | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display | April 24, 2024 |
| Z-0979-2024 | Class II | Barco MDSC-8527 NXF, Part Number K9352421 | December 20, 2023 |
| Z-1172-2021 | Class II | Barco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGY | January 22, 2021 |
| Z-0527-2019 | Class II | Optional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The p | March 30, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243307 | LCD Monitor (MDEC-2523) | December 13, 2024 |
| K242008 | Coronis OneLook | August 2, 2024 |
| K233693 | Nio Color 8MP (MDNC-8132) | December 11, 2023 |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | March 21, 2023 |
| K213957 | Demetra Dermatoscope BDEM-01 | March 11, 2022 |
| K203364 | MDPC-8127 | April 15, 2021 |
| K201408 | Demetra Analytics Toolkit | February 18, 2021 |
| K203106 | Nio Fusion 12MP (MDNC-12130) | November 10, 2020 |
| K192829 | Demetra BDEM-01 Dermatoscope | December 13, 2019 |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) | September 6, 2019 |
| K173381 | Nexxis OR | February 22, 2018 |
| K172922 | MMPC-4127F1 | December 21, 2017 |
| K171812 | Nio Color 2MP (MDNC-2123) | July 19, 2017 |
| K170537 | Nexxis OR, Nexxis | April 21, 2017 |
| K170837 | Nio Color 3MP (MDNC-3421) | April 5, 2017 |
| K170476 | Nio Color 5.8MP (MDNC-6121) | March 28, 2017 |
| K161880 | NIVR58-T kit | March 14, 2017 |
| K161229 | Mammo Tomosynthesis (MDMG-5221) | May 18, 2016 |
| K151505 | Coronis Uniti | July 17, 2015 |
| K133994 | SIVR56-T KIT | December 1, 2014 |