Medical Device Manufacturer · US , La Jolla , CA

Barco N.V. - FDA 510(k) Cleared Devices

60 submissions · 60 cleared · Since 1998

Recent clearances: LCD Monitor (MDEC-2523), Coronis OneLook, Nio Color 8MP (MDNC-8132)

Official Website

60

Total

60

Cleared

0

Denied

FDA 510(k) Regulatory Record - Barco N.V. Radiology ✕

49 devices

1-12 of 49

Cleared Aug 02, 2024

Coronis OneLook

Radiology · 23d

Cleared Dec 11, 2023

Nio Color 8MP (MDNC-8132)

Radiology · 24d

Cleared Mar 21, 2023

Nio Color 2MP (MDNC-2521)

Radiology · 22d

Cleared Nov 10, 2020

Nio Fusion 12MP (MDNC-12130)

Radiology · 26d

Cleared Sep 06, 2019

Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive...

Radiology · 58d

Cleared Jul 19, 2017

Nio Color 2MP (MDNC-2123)

Radiology · 30d

Cleared Apr 05, 2017

Nio Color 3MP (MDNC-3421)

Radiology · 15d

Cleared Mar 28, 2017

Nio Color 5.8MP (MDNC-6121)

Radiology · 40d

Cleared May 18, 2016

Mammo Tomosynthesis (MDMG-5221)

Radiology · 16d

Cleared Jul 17, 2015

Radiology · 43d

Cleared Nov 12, 2014

Coronis Fusion 4MP LED

Radiology · 9d

Cleared Jun 27, 2014

Radiology · 28d

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