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Barco N.V.

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
60
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1994-2025Class IIModel: Description/REF: MNA-420: MNA-420 ENC -H/K9303320, MNA-420 DEC -H V2/K9303331; MNA-440: MNAMay 9, 2025
Z-2332-2024Class IIMNA-420 ENC HDMI, Material Number K9303311; cathode ray tube displayApril 24, 2024
Z-0979-2024Class IIBarco MDSC-8527 NXF, Part Number K9352421December 20, 2023
Z-1172-2021Class IIBarco MDNC-3421 DISPLAY, DIAGNOSTIC RADIOLOGYJanuary 22, 2021
Z-0527-2019Class IIOptional MDRC-1119 Front Cover Attachment Kit for review display monitors. Product Usage: The pMarch 30, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K243307LCD Monitor (MDEC-2523)December 13, 2024
K242008Coronis OneLookAugust 2, 2024
K233693Nio Color 8MP (MDNC-8132)December 11, 2023
K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)March 21, 2023
K213957Demetra Dermatoscope BDEM-01March 11, 2022
K203364MDPC-8127April 15, 2021
K201408Demetra Analytics ToolkitFebruary 18, 2021
K203106Nio Fusion 12MP (MDNC-12130)November 10, 2020
K192829Demetra BDEM-01 DermatoscopeDecember 13, 2019
K191845Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)September 6, 2019
K173381Nexxis ORFebruary 22, 2018
K172922MMPC-4127F1December 21, 2017
K171812Nio Color 2MP (MDNC-2123)July 19, 2017
K170537Nexxis OR, NexxisApril 21, 2017
K170837Nio Color 3MP (MDNC-3421)April 5, 2017
K170476Nio Color 5.8MP (MDNC-6121)March 28, 2017
K161880NIVR58-T kitMarch 14, 2017
K161229Mammo Tomosynthesis (MDMG-5221)May 18, 2016
K151505Coronis UnitiJuly 17, 2015
K133994SIVR56-T KITDecember 1, 2014