510(k) · Cleared

Cleared

Monochrome LCD Monitor, Radiforce, GS320

K062053510(k) SpecialCleared Aug 7, 200618-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 Aug 7, 2006 as substantially equivalent to K060845 (Eizo Nanao Corporation, 2006) after an 18-day review. Its family tree reaches back 5 generations to 2000. 11 later devices descend from it.

Decided: Aug 7, 2006
Review: 18 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K000293 (2000). 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 5 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
4 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
3 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
2 generations backK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
1 generation backK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
This deviceK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
Descendant · cites it directly · 8 of its ownK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
Descendant · 2 generations on · 4 of its ownK201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
Descendant · 2 generations on · 2 of its ownK141690 Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014
Descendant · 3 generations on · 1 of its ownK240310 LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024
Descendant · 4 generations on · 0 of its ownK243031 LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007high 3 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 11 · See all

K1137843MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012 · cites it directly8descendants
K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 2 generations on4descendants
K141690Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014 · 2 generations on2descendants
K240310LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024 · 3 generations on1descendant
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd. · 2024 · 4 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K000293	Barco MGD 221 2 Megapixel Diagnostic Display	Barco N.V.	2000	—
−4	K012099	Monochrome Perfectly Flat Panel Displays, ME Series	Totoku Electric Co., Ltd.	2001	—
−3	K022109	Eizo, Model FC-2091	Eizo Nanao Corporation	2002	—
−2	K052337	Monochrome LCD Monitor, Model Radiforce G33	Eizo Nanao Corporation	2005	—
−1	K060845	Monochrome LCD Monitor, Radiforce Model GS310	Eizo Nanao Corporation	2006	—
0 (this device)	K062053	Monochrome LCD Monitor, Radiforce, GS320	Eizo Nanao Corporation	2006	—
+1	K113784	3MP Monochrome LCD Monitor, Radiforce GX340	Eizo Nanao Corporation	2012	—
+2	K201211	3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+	Shenzhen Beacon Display Technology Co., Ltd.	2020	—
+2	K141690	Jusha-M33C LCD Monitor	Nanjing Jusha Display Technology Co., Ltd.	2014	—
+3	K240310	LCD Monitors C310S, G310S, C316S, G316S, C616W	Shenzhen Beacon Display Technology Co., Ltd.	2024	—
+4	K243031	LCD Monitors C310S, G310S, C316S, G316S, C616W	Shenzhen Beacon Display Technology Co., Ltd.	2024	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2012	1	0
2014	1	0
2019	1	0
2020	1	0
2022	2	0
2024	3	0

FIG. 1 — Lineage of K062053, 2000–2024Source: 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
*	K060845	Monochrome LCD Monitor, Radiforce Model GS310 Summary page 1 …icate Device Manufacturer : EIZO NANAO CORPORATION Device Name : Monochrome LCD Monitor Model Name : RadiForce G310 510(k) No. : K060845 8. Description of Device RadiForce GS320 is a 54cm (21.3") Monochrome LCD display for medical image viewing. GS310 display…	Eizo Nanao Corporation	2006	—

Also cleared against K060845: 1 other device →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K113784	3MP Monochrome LCD Monitor, Radiforce GX340	Eizo Nanao Corporation	2012	8
K082496	Pacsmate MMD-3213M Monitor	Iei Technology Corp.	2008	0
K070122	Monochrome LCD Monitor, Model Radiforce GX320	Eizo Nanao Corporation	2007	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 6 years and passes through 3 companies; a new generation was cleared every 11 months on median.
None of the 5 ancestors has a recall.
Of its descendants, K113784 (Eizo Nanao Corporation, 2012) has gone furthest, with 8 descendants of its own.
1 other device also cites its predicate K060845.

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 GS320 is intended to be used in displaying and viewing digital images for

diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified

for digital mammography system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K062053 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062053: Monochrome LCD Monitor, Radiforce, GS320.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062053

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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