510(k) · Cleared

Cleared

2MP Medical Color Reference Display, Model MDC2130-2HC

K063579510(k) TraditionalCleared Dec 14, 200614-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

Chi Lin Technology Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Dec 14, 2006 as substantially equivalent to K061305 (Chi Lin Technology Co., Ltd., 2006) after a 14-day review. Its family tree reaches back 2 generations to 2004. 12 later devices descend from it.

Decided: Dec 14, 2006
Review: 14 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K040982 (2004). 12 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 2 generations backK040982 Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation · 2004
1 generation backK061305 Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006
This deviceK063579 2MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
Descendant · cites it directly · 5 of its ownK083916 LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor…Nec Display Solutions, Ltd. · 2009
Descendant · 2 generations on · 3 of its ownK111385 Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited · 2012
Descendant · 2 generations on · 3 of its ownK111237 MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd. · 2011
Descendant · cites it directly · 3 of its ownK083907 MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TGNec Display Solutions, Ltd. · 2009
Descendant · 3 generations on · 2 of its ownK131601 Dell U3014 with Qubyx Perfectlum BundleQubyx Limited · 2014

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2009high 4 (2009) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all

K083916LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TDNec Display Solutions, Ltd. · 2009 · cites it directly5descendants
K111385Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited · 2012 · 2 generations on3descendants
K111237MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd. · 2011 · 2 generations on3descendants
K083907MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TGNec Display Solutions, Ltd. · 2009 · cites it directly3descendants
K131601Dell U3014 with Qubyx Perfectlum BundleQubyx Limited · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K040982	Color LCD Monitor, Model Radiforce R12	Eizo Nanao Corporation	2004	—
−1	K061305	Medical Display, MDC1900-1LG (1LR)	Chi Lin Technology Co., Ltd.	2006	—
0 (this device)	K063579	2MP Medical Color Reference Display, Model MDC2130-2HC	Chi Lin Technology Co., Ltd.	2006	—
+1	K083916	LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TD	Nec Display Solutions, Ltd.	2009	—
+2	K111385	Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle	Qubyx Limited	2012	—
+2	K111237	MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY	Nec Display Solutions, Ltd.	2011	—
+1	K083907	MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG	Nec Display Solutions, Ltd.	2009	—
+3	K131601	Dell U3014 with Qubyx Perfectlum Bundle	Qubyx Limited	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	4	0
2011	1	0
2012	1	0
2013	2	0
2014	2	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K063579, 2004–2020Source: 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
*	K061305	Medical Display, MDC1900-1LG (1LR) Summary page 1 …ical (CLASS II CFR 892.2050) 4. PREDICATE DEVICE Medical Display - MDCI900-ILG 19" color LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061305). 5. DEVICE DESCRIPTION Medical Display, MDC213O-2HC is a 21.3" color LCD monitor that displays image for medica…	Chi Lin Technology Co., Ltd.	2006	—

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K083916	LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TD	Nec Display Solutions, Ltd.	2009	5
K083907	MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG	Nec Display Solutions, Ltd.	2009	3
K090218	MD213MC 21.3 Diagnostic Imaging LCD Monitor Model, L218TJ	Nec Display Solutions, Ltd.	2009	0
K083332	MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK	Nec Display Solutions, Ltd.	2009	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 2.0 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K083916 (Nec Display Solutions, Ltd., 2009) has gone furthest, with 5 descendants of its own.

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?

2MP Medical Color Reference Display, MDC2130-2HC is

intended to use in displaying images for review and analysis by trained medical

practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for

a digital mammography system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063579 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063579: 2MP Medical Color Reference Display, Model MDC2130-2HC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063579

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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