BARCO N.V.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
9613188	3004455125	BARCO N.V.	1	N	2026-01-01	35 PRESIDENT KENNEDYPARK KORTRIJK West-Vlaanderen BE 8500

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
17234	1081047827	K243307	LCD Monitor (MDEC-2523)	GCJ	2024-12-13
17234	1271867282	K242008	Coronis OneLook	PGY	2024-08-02
17234	1018228907	K233693	Nio Color 8MP (MDNC-8132)	PGY	2023-12-11
17234	1878005797	K230520	Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)	PGY	2023-03-21
17234	1450828805	K203364	MDPC-8127	PSY	2021-04-15
17234	1636592173	K203106	Nio Fusion 12MP (MDNC-12130)	PGY	2020-11-10
17234	1763322294	K202084	DeepLook PRECISE	LLZ	2021-04-09
17234	1127329053	K192829	Demetra BDEM-01 Dermatoscope	PSN	2019-12-13
17234	1729140116	K191845	Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT)	PGY	2019-09-06
17234	1968305130	K173381	Nexxis OR	DXJ	2018-02-22
17234	1272001773	K171812	Nio Color 2MP (MDNC-2123)	PGY	2017-07-19
17234	1115542410	K170837	Nio Color 3MP (MDNC-3421)	PGY	2017-04-05
17234	1579180673	K170537	Nexxis OR, Nexxis	DXJ	2017-04-21
17234	1037615625	K170476	Nio Color 5.8MP (MDNC-6121)	PGY	2017-03-28
17234	1529711091	K161229	Mammo Tomosynthesis (MDMG-5221)	PGY	2016-05-18
17234	1535582668	K151505	Coronis Uniti	PGY	2015-07-17
17234	1381447418	K150821	MDNG-3220 (Nio 3MP LED)	PGY	2015-04-10
17234	1346843726	K143157	Coronis Fusion 4MP LED	PGY	2014-11-12
17234	1190872425	K141428	MDMC-12133	PGY	2014-06-27
17234	1121512863	K133984	CORONIS 5MP	LLZ	2014-03-28
17234	1103144152	K133663	NIO COLOR 2MP	LLZ	2014-03-25
17234	1711879839	K131295	NIO COLOR 3MP LED	LLZ	2013-05-29
17234	1513513396	K131246	CORONIS 3MP	LLZ	2013-05-24
17234	1058967008	K130103	CORONIS FUSION 6MP	LLZ	2013-02-08
17234	1507414041	K122167	NEXXIS OR	DXJ	2013-04-22
17234	1749414554	K111991	NIO COLOR 2MP	LLZ	2011-08-11
17234	1001722505	K111990	CORONIS 5MP	LLZ	2011-10-17
17234	1513882155	K111989	CORONIS FUSION 4MP DL	LLZ	2011-09-22
17234	1340472906	K103792	BARCO MAMMO TOMOSYNTHESIS	LLZ	2011-03-04
17234	1231296754	K093197	CORONIS FUSION 10MP, MODEL MDCG-10130	LLZ	2010-06-23
17234	1116111952	K091274	CORONIS 5MP HD, MODEL MDMG 5121	LLZ	2009-07-14
17234	1661618231	K091172	NIO 2MP (MDNG-2121)	LLZ	2009-05-05
17234	1381749159	K090732	NIO COLOR 3MP AND MDNC-3121	LLZ	2009-04-20
17234	1653557860	K081109	CORONIS 5MP MAMMO SL, MODEL MDMG 6121	LLZ	2008-05-02
17234	1278245295	K073205	NIO 5MP, MODEL MDNG-5121	LLZ	2007-12-19
17234	1893643288	K073007	CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL	LLZ	2008-02-14
17234	1395069518	K070726	NIO COLOR 3MP AND MDNC 3120	LLZ	2007-05-02
17234	1626893332	K062905	NIO FUSION 4MP; MDNC 4130	LLZ	2006-12-29
17234	1215260919	K062621	NIO 5MP-21 AND MDNG-5121 CB	LLZ	2007-03-19
17234	1108380234	K062131	NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB	LLZ	2006-11-17
17234	1516795640	K061928	CORONIS COLOR 2MP AND MDCC 2121	LLZ	2006-09-05
17234	1976638656	K061927	CORONIS COLOR 3MP AND MDCC 3120-DL	LLZ	2006-09-05
17234	2016357458	K061926	CORONIS 2MP AND MDCG 2121 - CB	LLZ	2006-08-18
17234	1806566350	K061924	CORONIS 3MP AND MDCG 3120-CB	LLZ	2006-09-05
17234	1010097968	K052958	COLOR NIO 2MP, E-2320 C	LLZ	2005-11-16
17234	1239578726	K052478	MFCD 1219, MFCD 1219 TS	LLZ	2005-09-28
17234	1673609303	K051901	NIO 3MP-21	LLZ	2005-08-17
17234	1734855859	K042661	NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM	LLZ	2004-11-19
17234	1169054136	K042221	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	LLZ	2004-12-30
17234	1212884113
17234	1431815030
17234	2060384178

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LLZ	30	2021-04-09
PGY	13	2024-08-02
DXJ	3	2018-02-22
GCJ	1	2024-12-13
PSY	1	2021-04-15
PSN	1	2019-12-13

PMN#

LCD Monitor (MDEC-2523)
2024-12-13
Barco N.V.
Coronis OneLook
2024-08-02
Barco N.V.
Nio Color 8MP (MDNC-8132)
2023-12-11
Barco N.V.
Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)
2023-03-21
Barco N.V.
Nexxis OR
2018-02-22
Barco N.v.
MMPC-4127F1
2017-12-21
Barco N.V.
Nexxis OR, Nexxis
2017-04-21
Barco N.v.
NIVR58-T Kit
2017-03-14
Barco N.V.
Mammo Tomosynthesis (MDMG-5221)
2016-05-18
BARCO N.V.
Coronis Uniti
2015-07-17
Barco N.V.
SIVR56-T KIT
2014-12-01
BARCO N.V.
MDMC-12133
2014-06-27
BARCO N.V.
NIO COLOR 2MP
2014-03-25
BARCO N.V.
CORONIS 3MP
2013-05-24
BARCO N.V.
CORONIS FUSION 6MP
2013-02-08
BARCO N.V.