510(k) · Cleared

Cleared

Color LCD Monitor, Model Radioforce R31 & R31-C

K052344510(k) SpecialCleared Sep 14, 200519-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 Sep 14, 2005 as substantially equivalent to K033466 (Eizo Nanao Corporation, 2004) after a 19-day review. Its family tree reaches back 1 generation to 2004. 45 later devices descend from it.

Decided: Sep 14, 2005
Review: 19 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033466 (2004). 45 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK033466 Color LCD Display, Model Radiforce R22Eizo Nanao Corporation · 2004
This deviceK052344 Color LCD Monitor, Model Radioforce R31 & R31-CEizo Nanao Corporation · 2005
Descendant · cites it directly · 35 of its ownK090045 Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009
Descendant · 2 generations on · 34 of its ownK113562 3MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
Descendant · 3 generations on · 17 of its ownK153354 3MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016
Descendant · 3 generations on · 14 of its ownK134002 6MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · Recalled
Descendant · 4 generations on · 7 of its ownK182591 RadiForce RX360, RX360-AREizo Corporation · 2018 · Recalled

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2007high 7 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 45 · See all

K090045Color LCD Monitor, Radiforce RX320Eizo Nanao Corporation · 2009 · cites it directly35descendants
K1135623MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012 · 2 generations on34descendants
K1533543MP Color LCD Monitor, RadiForce RX350Eizo Corporation · 2016 · 3 generations on17descendants
K1340026MP Color LCD Monitor, Radiforce RX650Eizo Corporation · 2014 · 3 generations on14descendants
K182591RadiForce RX360, RX360-AREizo Corporation · 2018 · 4 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033466	Color LCD Display, Model Radiforce R22	Eizo Nanao Corporation	2004	—
0 (this device)	K052344	Color LCD Monitor, Model Radioforce R31 & R31-C	Eizo Nanao Corporation	2005	—
+1	K090045	Color LCD Monitor, Radiforce RX320	Eizo Nanao Corporation	2009	—
+2	K113562	3MP Color LCD Monitor, Radiforce RX340	Eizo Nanao Corporation	2012	—
+3	K153354	3MP Color LCD Monitor, RadiForce RX350	Eizo Corporation	2016	—
+3	K134002	6MP Color LCD Monitor, Radiforce RX650	Eizo Corporation	2014	1
+4	K182591	RadiForce RX360, RX360-AR	Eizo Corporation	2018	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	3	0
2011	2	0
2012	1	0
2013	1	0
2014	4	0
2015	1	0
2016	3	0
2017	2	0
2018	2	0
2019	3	0
2020	2	0
2021	3	0
2022	4	0
2023	7	0
2024	4	0
2026	1	0

FIG. 1 — Lineage of K052344, 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
*	K033466	Color LCD Display, Model Radiforce R22 Summary page 1 …icate Device Manufacturer : EIZO NANAO CORPORATION Device Name : 20.8" Color LCD Monitor Model Name : RadiForce R22 510(k) No. : K033466 8. Description of Device RadiForce R31 and R31-C are 53cm (20.8") Color LCD displays for medical viewing. Each model produ…	Eizo Nanao Corporation	2004	—

Also cleared against K033466: 1 other device →

What descends from it? (45)

See all 45

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

Number	Device	Applicant	Decided	Descendants
K090045	Color LCD Monitor, Radiforce RX320	Eizo Nanao Corporation	2009	35
K073340	Color LCD Monitor, Flexscan MX300W	Eizo Nanao Corporation	2007	6
K131389	Jusha-C31 Medical Display	Nanjing Jusha Display Technology Co., Ltd.	2013	0
K080320	Primevue 21 3MP Color Display, Model AC-QX21-A9300	Nds Surgical Imaging	2008	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?

Its one ancestor has no recall.
Of its descendants, K090045 (Eizo Nanao Corporation, 2009) has gone furthest, with 35 descendants of its own.
1 other device also cites its predicate K033466.

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?

RadiForce R31 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. These devices must not be used for digital mammography system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052344 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052344: Color LCD Monitor, Model Radioforce R31 & R31-C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052344

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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