510(k) · Cleared

Cleared

3MP Color LCD Monitor, Radiforce RX340

K113562510(k) TraditionalCleared Jul 16, 2012228-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

Eizo Nanao Corporation · LLZ System, Image Processing, Radiological

Cleared on Jul 16, 2012 as substantially equivalent to K090045 (Eizo Nanao Corporation, 2009) after a 228-day review. Its family tree reaches back 3 generations to 2004. 34 later devices descend from it.

Decided: Jul 16, 2012
Review: 228 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K033466 (2004). 34 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 3 generations backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
2 generations backK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
1 generation backK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
This deviceK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
Descendant · cites it directly · 17 of its ownK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
Descendant · cites it directly · 14 of its ownK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
Descendant · 2 generations on · 7 of its ownK182591 RadiForce RX360, RX360-AREizo Corporation · 2018 · Recalled
Descendant · 2 generations on · 5 of its ownK191864 21HK512DLg Electronics.Inc · 2019
Descendant · 2 generations on · 5 of its ownK141679 Jusha-C61 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2014high 6 (2023) · low 0 (2025)2026

Most influential descendants

Showing 5 of 34 · See all

K1533543MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016 · cites it directly17descendants
K1340026MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · cites it directly14descendants
K182591RadiForce RX360, RX360-AREizo Corporation · 2018 · 2 generations on7descendants
K19186421HK512DLg Electronics.Inc · 2019 · 2 generations on5descendants
K141679Jusha-C61 LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014 · 2 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K033466	Color LCD Display, Model Radiforce R22	Eizo Nanao Corporation	2004	—
−2	K052344	Color LCD Monitor, Model Radioforce R31 & R31-C	Eizo Nanao Corporation	2005	—
−1	K090045	Color LCD Monitor, Radiforce RX320	Eizo Nanao Corporation	2009	—
0 (this device)	K113562	3MP Color LCD Monitor, Radiforce RX340	Eizo Nanao Corporation	2012	—
+1	K153354	3MP Color LCD Monitor, RadiForce RX350	Eizo Corporation	2016	—
+1	K134002	6MP Color LCD Monitor, Radiforce RX650	Eizo Corporation	2014	1
+2	K182591	RadiForce RX360, RX360-AR	Eizo Corporation	2018	1
+2	K191864	21HK512D	Lg Electronics.Inc	2019	—
+2	K141679	Jusha-C61 LCD Monitor	Nanjing Jusha Display Technology Co., Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	4	0
2015	1	0
2016	3	0
2017	1	0
2018	2	0
2019	3	0
2020	2	0
2021	3	0
2022	4	0
2023	6	0
2024	4	0
2026	1	0

FIG. 1 — Lineage of K113562, 2004–2026Source: 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
*	K090045	Color LCD Monitor, Radiforce RX320 Summary page 1 …cessing, Radiological * Classification Number: 21 CFR 892.2050, Product Code LLZ 5. Predicate Device * Color LCD Monitor, RadiForce RX320 (K090045) 6. Device Description I The RadiForce RX340 is a color LCD monitor for viewing medical images other than…	Eizo Nanao Corporation	2009	—

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K153354	3MP Color LCD Monitor, RadiForce RX350	Eizo Corporation	2016	17
K134002	6MP Color LCD Monitor, Radiforce RX650	Eizo Corporation	2014	14
K143098	3MP Color LCD monitor, RadiForce RS340	Eizo Corporation	2014	1
K141684	Jusha-C33C LCD Monitor	Nanjing Jusha Display Technology Co., Ltd.	2014	1

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 8 years and passes through 1 company; a new generation was cleared every 3.4 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K153354 (Eizo Corporation, 2016) has gone furthest, with 17 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. 2012, this device’s year, is highlighted.

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 RadiForce RX340 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MMI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K113562 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113562: 3MP Color LCD Monitor, Radiforce RX340.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113562

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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