510(k) · Cleared

Cleared

MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display

K033004510(k) TraditionalCleared Apr 16, 2004204-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barco NV Barcoview · LLZ System, Image Processing, Radiological

Cleared on Apr 16, 2004 as substantially equivalent to K023322 (Barco N.V., 2002) after a 204-day review. Its family tree reaches back 3 generations to 2000. 10 later devices descend from it.

Decided: Apr 16, 2004
Review: 204 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K001753 (2000). 10 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
2 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
1 generation backK023322 Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002
This deviceK033004 MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004
Descendant · cites it directly · 5 of its ownK052403 Coronis 2MP-21 and MFGD 2621Barcoview · 2005
Descendant · 2 generations on · 1 of its ownK061927 Coronis Color 3MP and MDCC 3120-DLBarcoview · 2006
Descendant · cites it directly · 1 of its ownK052276 Nio 2MP-20 and E-2620 SBarcoview · 2005
Descendant · 3 generations on · 0 of its ownK080320 Primevue 21 3MP Color Display, Model AC-QX21-A9300Nds Surgical Imaging · 2008
Descendant · 2 generations on · 0 of its ownK061924 Coronis 3MP and MDCG 3120-CBBarcoview · 2006

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005high 5 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 10 · See all

K052403Coronis 2MP-21 and MFGD 2621Barcoview · 2005 · cites it directly5descendants
K061927Coronis Color 3MP and MDCC 3120-DLBarcoview · 2006 · 2 generations on1descendant
K052276Nio 2MP-20 and E-2620 SBarcoview · 2005 · cites it directly1descendant
K080320Primevue 21 3MP Color Display, Model AC-QX21-A9300Nds Surgical Imaging · 2008 · 3 generations on0descendants
K061924Coronis 3MP and MDCG 3120-CBBarcoview · 2006 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K001753	Medis 5MP2 Dual-Head Medical Diagnostic Display System	Barco NV Display Systems	2000	—
−2	K013922	Coronis 3MP Medicl Flat Panel Display System	Barco N.V.	2002	—
−1	K023322	Coronis 2MP Medical Flat Panel Display System	Barco N.V.	2002	—
0 (this device)	K033004	MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display	Barco NV Barcoview	2004	—
+1	K052403	Coronis 2MP-21 and MFGD 2621	Barcoview	2005	—
+2	K061927	Coronis Color 3MP and MDCC 3120-DL	Barcoview	2006	—
+1	K052276	Nio 2MP-20 and E-2620 S	Barcoview	2005	—
+3	K080320	Primevue 21 3MP Color Display, Model AC-QX21-A9300	Nds Surgical Imaging	2008	—
+2	K061924	Coronis 3MP and MDCG 3120-CB	Barcoview	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	4	0
2006	5	0
2008	1	0

FIG. 1 — Lineage of K033004, 2000–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LLZ device

#1 K230955 syngo Application Softwarescore 21.6 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K023322	Coronis 2MP Medical Flat Panel Display System Summary page 1 …n Number: 21 CFR 892.2050/Procode 9OLLZ Substantial Equivalence: Coronis 2MP Medical Flat Panel Display System (K0233 22) Device Description: The MFGD 2320 is a diagnostic display Intended Use: The MFGD 2320 devi…	Barco N.V.	2002	—

Also cleared against K023322: 6 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K052403	Coronis 2MP-21 and MFGD 2621	Barcoview	2005	5
K052276	Nio 2MP-20 and E-2620 S	Barcoview	2005	1
K052429	Coronis 3MP-21 and MFGD 3621	Barcoview	2005	0
K051901	NIO 3MP-21	Barcoview	2005	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K052403 (Barcoview, 2005) has gone furthest, with 5 descendants of its own.
6 other devices also cite its predicate K023322.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

The MFGD 2320 20 Inch 2 Megapixel Grayscale LCD Display is intended to be used as a tool in displaying and viewing digital images (excluding digital Mammography) for review and analysis by trained medical practitioners.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K033004 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033004: MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033004

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026