510(k) · Cleared

Cleared

20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB

K050619510(k) TraditionalCleared Apr 26, 200547-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

Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Apr 26, 2005 as substantially equivalent to K043430 (Totoku Electric Co., Ltd., 2005) after a 47-day review. Its family tree reaches back 2 generations to 2004. 7 later devices descend from it.

Decided: Apr 26, 2005
Review: 47 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K032555 (2004). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 2 generations backK032555 3M Color Medical Flat Panel Display, CCL316Totoku Electric Co., Ltd. · 2004
1 generation backK043430 20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HBTotoku Electric Co., Ltd. · 2005
This deviceK050619 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I &…Totoku Electric Co., Ltd. · 2005
Descendant · cites it directly · 5 of its ownK072065 20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007
Descendant · 2 generations on · 4 of its ownK081056 21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008
Descendant · 3 generations on · 3 of its ownK112604 21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
Descendant · 4 generations on · 2 of its ownK133185 21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013
Descendant · 5 generations on · 1 of its ownK140214 30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2006high 1 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all

K07206520.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)Totoku Electric Co., Ltd. · 2007 · cites it directly5descendants
K08105621.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)Totoku Electric Co., Ltd. · 2008 · 2 generations on4descendants
K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011 · 3 generations on3descendants
K13318521.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)Jvckenwood Corporation · 2013 · 4 generations on2descendants
K14021430.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)Jvckenwood Corporation · 2014 · 5 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K032555	3M Color Medical Flat Panel Display, CCL316	Totoku Electric Co., Ltd.	2004	—
−1	K043430	20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB	Totoku Electric Co., Ltd.	2005	—
0 (this device)	K050619	20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB	Totoku Electric Co., Ltd.	2005	—
+1	K072065	20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)	Totoku Electric Co., Ltd.	2007	—
+2	K081056	21.3 (54CM) 3M Color LCD Monitor CCL354I2 (CDL2126A)	Totoku Electric Co., Ltd.	2008	—
+3	K112604	21.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)	Totoku Electric Co., Ltd.	2011	—
+4	K133185	21.3 Inch (54 CM) Color LCD Monitor CCL358I2 (CL21358)	Jvckenwood Corporation	2013	—
+5	K140214	30.0 Inch Color LCD Monitor CCL650I2 (CL30650, MD302C6)	Jvckenwood Corporation	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2011	1	0
2013	1	0
2014	1	0
2021	1	0

FIG. 1 — Lineage of K050619, 2004–2021Source: 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

Get a 510(k) Report

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
*	K043430	20.8-Inch (53 CM) Color LCD Monitor, Models CDL2114A and DV3MC-HB Summary page 1 …(Part:892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System) Predicate Device: CDL2114A (K043430) Device Description: CDL2112A (CCL35Oi) (DV3MC-HB) is a 20.8-inch Color LCD Monitor that s…	Totoku Electric Co., Ltd.	2005	—

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K072065	20.8-Inch (53CM) Color LCD Monitor CDL2119A (CCL352I2)	Totoku Electric Co., Ltd.	2007	5
K060210	Mediport	Maxant Technologies, Inc.	2006	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 1 year and passes through 1 company; a new generation was cleared every 11 months on median.
None of the 2 ancestors has a recall.
Of its descendants, K072065 (Totoku Electric Co., Ltd., 2007) 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?

20.8-inch (53cm) Color LCD Monitor CDL2112A (CCL350i) (DV3MC-HB) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050619 · printed Nov 5, 2026

Cite this page

510(k) Report. “K050619: 20.8-Inch (53CM) Color LCD Monitor, Models CDL2112A, CCL350I & DV3MC-HB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050619

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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