510(k) · Cleared

Cleared

Cornis 5MP Medical Flat Panel Display System

K023341510(k) TraditionalCleared Dec 23, 200277-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 N.V. · LLZ System, Image Processing, Radiological

Cleared on Dec 23, 2002 as substantially equivalent to K013922 (Barco N.V., 2002) after a 77-day review. Its family tree reaches back 2 generations to 2000. 17 later devices descend from it.

Decided: Dec 23, 2002
Review: 77 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K001753 (2000). 17 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 2 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
1 generation backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
This deviceK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
Descendant · cites it directly · 10 of its ownK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
Descendant · 2 generations on · 7 of its ownK040443 Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004
Descendant · 3 generations on · 6 of its ownK042221 Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
Descendant · cites it directly · 4 of its ownK041508 Barcoview Coronis 5MP HD Medical Flat Panel Display SystemBarco NV Barcoview · 2004
Descendant · 4 generations on · 2 of its ownK062131 Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003high 5 (2004) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all

K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003 · cites it directly10descendants
K040443Dome CX Digital Flat-Panel Display System, Model C5IDome Imaging Systems, Inc. · 2004 · 2 generations on7descendants
K042221Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004 · 3 generations on6descendants
K041508Barcoview Coronis 5MP HD Medical Flat Panel Display SystemBarco NV Barcoview · 2004 · cites it directly4descendants
K062131Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BBBarcoview · 2006 · 4 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K001753	Medis 5MP2 Dual-Head Medical Diagnostic Display System	Barco NV Display Systems	2000	—
−1	K013922	Coronis 3MP Medicl Flat Panel Display System	Barco N.V.	2002	—
0 (this device)	K023341	Cornis 5MP Medical Flat Panel Display System	Barco N.V.	2002	—
+1	K032202	Dome CX Digital Flat-Panel Display System, Models C2 and C5I	Planar Systems, Inc.	2003	—
+2	K040443	Dome CX Digital Flat-Panel Display System, Model C5I	Dome Imaging Systems, Inc.	2004	—
+3	K042221	Coronis 5MP Medical Flat Panel Display System	Barco NV Barcoview	2004	—
+1	K041508	Barcoview Coronis 5MP HD Medical Flat Panel Display System	Barco NV Barcoview	2004	—
+4	K062131	Nio 5MP-M-21 (Nio 5MP Mammo); MDNG-5121 BB	Barcoview	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	5	0
2005	2	0
2006	1	0
2007	2	0
2008	1	0
2013	1	0
2014	1	0
2016	2	0

FIG. 1 — Lineage of K023341, 2000–2016Source: 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 21.5 · 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
*	K013922	Coronis 3MP Medicl Flat Panel Display System Summary page 1 …FR 892.2050/Procode 90LLZ Substantial Equivalence: Barco NV Display !systems Coronis 3MP Medical Flat Panel Display System (K013922) Device Desaiption: The Coronis 5MP device is a digital image display system…	Barco N.V.	2002	—

Also cleared against K013922: 16 other devices →

What descends from it? (17)

See all 17

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

Number	Device	Applicant	Decided	Descendants
K032202	Dome CX Digital Flat-Panel Display System, Models C2 and C5I	Planar Systems, Inc.	2003	10
K041508	Barcoview Coronis 5MP HD Medical Flat Panel Display System	Barco NV Barcoview	2004	4
K040310	Nova Family of Medical Radiology Displays	National Display Systems	2004	1
K042353	Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome Displays	National Display Systems	2004	0
K031929	5MP TFT LCD Monitor System IF2105A by Wide Corporation	Wide Corporation	2003	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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K032202 (Planar Systems, Inc., 2003) has gone furthest, with 10 descendants of its own.
16 other devices also cite its predicate K013922.

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 Coronis 5MP Medical Flat Panel Display System is

intended to be used in displaying and viewing digital images

for review and analysis by trained medical practitioners.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023341 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023341: Cornis 5MP Medical Flat Panel Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023341

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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