Medical Device Manufacturer · US , La Jolla , CA

Barco N.V.

60 submissions · 60 cleared · Since 1998
60
Total
60
Cleared
0
Denied

Barco N.V. — FDA 510(k) Submissions

Barco N.V. has submitted 60 FDA 510(k) premarket notifications since 1998, of which 60 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Image Processing, Radiological, Display, Diagnostic Radiology, Display, Cathode-ray Tube, Medical, Light Based Imaging, Digital Pathology Display . Use the specialty filter in the sidebar to narrow results.

60 devices
1–25 of 60
LCD Monitor (MDEC-2523)
K243307 · GCJ Laparoscope, General &... · General & Plastic Surgery
Dec 2024 53d
Coronis OneLook
K242008 · PGY Display, Diagnostic... · Radiology
Aug 2024 23d
Nio Color 8MP (MDNC-8132)
K233693 · PGY Display, Diagnostic... · Radiology
Dec 2023 24d
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
K230520 · PGY Display, Diagnostic... · Radiology
Mar 2023 22d
Demetra Dermatoscope BDEM-01
K213957 · PSN Light Based Imaging · General & Plastic Surgery
Mar 2022 84d
MDPC-8127
K203364 · PSY Whole Slide Imaging System · Pathology
Apr 2021 150d
Demetra Analytics Toolkit
K201408 · PSN Light Based Imaging · General & Plastic Surgery
Feb 2021 266d
Nio Fusion 12MP (MDNC-12130)
K203106 · PGY Display, Diagnostic... · Radiology
Nov 2020 26d
Demetra BDEM-01 Dermatoscope
K192829 · PSN Light Based Imaging · General & Plastic Surgery
Dec 2019 72d
Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)
K191845 · PGY Display, Diagnostic... · Radiology
Sep 2019 58d
Nexxis OR
K173381 · DXJ Display, Cathode-ray... · Cardiovascular
Feb 2018 115d
MMPC-4127F1
K172922 · PZZ Digital Pathology Display · Pathology
Dec 2017 87d
Nio Color 2MP (MDNC-2123)
K171812 · PGY Display, Diagnostic... · Radiology
Jul 2017 30d
Nexxis OR, Nexxis
K170537 · DXJ Display, Cathode-ray... · Cardiovascular
Apr 2017 57d
Nio Color 3MP (MDNC-3421)
K170837 · PGY Display, Diagnostic... · Radiology
Apr 2017 15d
Nio Color 5.8MP (MDNC-6121)
K170476 · PGY Display, Diagnostic... · Radiology
Mar 2017 40d
NIVR58-T kit
K161880 · DXJ Display, Cathode-ray... · Cardiovascular
Mar 2017 249d
Mammo Tomosynthesis (MDMG-5221)
K161229 · PGY Display, Diagnostic... · Radiology
May 2016 16d
Coronis Uniti
K151505 · PGY Display, Diagnostic... · Radiology
Jul 2015 43d
SIVR56-T KIT
K133994 · DXJ Display, Cathode-ray... · Cardiovascular
Dec 2014 340d
Coronis Fusion 4MP LED
K143157 · PGY Display, Diagnostic... · Radiology
Nov 2014 9d
MDMC-12133
K141428 · PGY Display, Diagnostic... · Radiology
Jun 2014 28d
CORONIS 5MP
K133984 · LLZ System, Image Processing,... · Radiology
Mar 2014 92d
NIO COLOR 2MP
K133663 · LLZ System, Image Processing,... · Radiology
Mar 2014 116d
NIO COLOR 3MP LED
K131295 · LLZ System, Image Processing,... · Radiology
May 2013 23d
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