Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Barco N.V. — Predicate Candidate Screening
60 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
184 days90th percentile
60clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243307 | LCD Monitor (MDEC-2523) | Barco N.V. | 2024-12-13 | 53 | 0 |
| K242008 | Coronis OneLook | Barco N.V. | 2024-08-02 | 23 | 0 |
| K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023-12-11 | 24 | 0 |
| K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023-03-21 | 22 | 0 |
| K213957 | Demetra Dermatoscope BDEM-01 | Barco N.V. | 2022-03-11 | 84 | 0 |
| K203364 | MDPC-8127 | Barco N.V. | 2021-04-15 | 150 | 0 |
| K201408 | Demetra Analytics Toolkit | Barco N.V. | 2021-02-18 | 266 | 0 |
| K203106 | Nio Fusion 12MP (MDNC-12130) | Barco N.V. | 2020-11-10 | 26 | 0 |
| K192829 | Demetra BDEM-01 Dermatoscope | Barco N.V. | 2019-12-13 | 72 | 0 |
| K191845 | Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-44 | Barco N.V. | 2019-09-06 | 58 | 0 |
| K173381 | Nexxis OR | Barco N.V. | 2018-02-22 | 115 | 3 |
| K172922 | MMPC-4127F1 | Barco N.V. | 2017-12-21 | 87 | 0 |
| K171812 | Nio Color 2MP (MDNC-2123) | Barco N.V. | 2017-07-19 | 30 | 0 |
| K170537 | Nexxis OR, Nexxis | Barco N.V. | 2017-04-21 | 57 | 0 |
| K170837 | Nio Color 3MP (MDNC-3421) | Barco N.V. | 2017-04-05 | 15 | 0 |
| K170476 | Nio Color 5.8MP (MDNC-6121) | Barco N.V. | 2017-03-28 | 40 | 0 |
| K161880 | NIVR58-T kit | Barco N.V. | 2017-03-14 | 249 | 0 |
| K161229 | Mammo Tomosynthesis (MDMG-5221) | Barco N.V. | 2016-05-18 | 16 | 0 |
| K151505 | Coronis Uniti | Barco N.V. | 2015-07-17 | 43 | 0 |
| K133994 | SIVR56-T KIT | Barco N.V. | 2014-12-01 | 340 | 0 |
| K143157 | Coronis Fusion 4MP LED | Barco N.V. | 2014-11-12 | 9 | 0 |
| K141428 | MDMC-12133 | Barco N.V. | 2014-06-27 | 28 | 0 |
| K133984 | CORONIS 5MP | Barco N.V. | 2014-03-28 | 92 | 0 |
| K133663 | NIO COLOR 2MP | Barco N.V. | 2014-03-25 | 116 | 0 |
| K131295 | NIO COLOR 3MP LED | Barco N.V. | 2013-05-29 | 23 | 0 |
| K131246 | CORONIS 3MP | Barco N.V. | 2013-05-24 | 23 | 0 |
| K122167 | NEXXIS OR | Barco N.V. | 2013-04-22 | 273 | 0 |
| K130103 | CORONIS FUSION 6MP | Barco N.V. | 2013-02-08 | 24 | 0 |
| K121788 | NIO 5MP | Barco N.V. | 2012-07-23 | 35 | 0 |
| K111990 | CORONIS 5MP | Barco N.V. | 2011-10-17 | 96 | 0 |
| K111989 | CORONIS FUSION 4MP DL | Barco N.V. | 2011-09-22 | 71 | 0 |
| K111991 | NIO COLOR 2MP | Barco N.V. | 2011-08-11 | 29 | 0 |
| K103792 | BARCO MAMMO TOMOSYNTHESIS | Barco N.V. | 2011-03-04 | 67 | 0 |
| K093197 | CORONIS FUSION 10MP, MODEL MDCG-10130 | Barco N.V. | 2010-06-23 | 257 | 0 |
| K091274 | CORONIS 5MP HD, MODEL MDMG 5121 | Barco N.V. | 2009-07-14 | 75 | 0 |
| K091172 | NIO 2MP (MDNG-2121) | Barco N.V. | 2009-05-05 | 13 | 0 |
| K090603 | BARCO 5MP MAMMO, MODEL MDMG-5221 | Barco N.V. | 2009-04-22 | 48 | 0 |
| K090732 | NIO COLOR 3MP AND MDNC-3121 | Barco N.V. | 2009-04-20 | 32 | 0 |
| K040365 | COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2004-04-28 | 75 | 0 |
| K040158 | MFCD 2320 | Barco N.V. | 2004-04-12 | 80 | 0 |
| K040039 | NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM | Barco N.V. | 2004-03-17 | 68 | 0 |
| K023533 | BARCO MEDIS 5MP2 AURA | Barco N.V. | 2003-01-17 | 88 | 0 |
| K023339 | IMAGETILE | Barco N.V. | 2002-12-23 | 77 | 0 |
| K023340 | CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | 77 | 0 |
| K023341 | CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | 77 | 0 |
| K023322 | CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM | Barco N.V. | 2002-12-23 | 80 | 0 |
| K022773 | BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM | Barco N.V. | 2002-12-13 | 114 | 0 |
| K020073 | MEDICAL ADMINISTRATOR | Barco N.V. | 2002-07-12 | 184 | 0 |
| K020058 | MEDICAL LE | Barco N.V. | 2002-04-04 | 86 | 0 |
| K020061 | IMAGEDESK | Barco N.V. | 2002-04-03 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda