510(k) · Cleared

Cleared

Monochrome LCD Monitor, Model Radiforce G22

K041597510(k) SpecialCleared Jun 24, 200430-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 Jun 24, 2004 as substantially equivalent to K022109 (Eizo Nanao Corporation, 2002) after a 30-day review. Its family tree reaches back 3 generations to 2000. 16 later devices descend from it.

Decided: Jun 24, 2004
Review: 30 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K000293 (2000). 16 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
2 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
1 generation backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
This deviceK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
Descendant · cites it directly · 9 of its ownK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
Descendant · 2 generations on · 7 of its ownK063266 3MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006
Descendant · 3 generations on · 6 of its ownK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
Descendant · cites it directly · 5 of its ownK070131 Radiforce GX220 and GS220 Monochrome LCD MonitorsEizo Nanao Corporation · 2007
Descendant · 4 generations on · 4 of its ownK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2006high 3 (2006) · low 0 (2008)2026

Most influential descendants

Showing 5 of 16 · See all

K061303Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006 · cites it directly9descendants
K0632663MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006 · 2 generations on7descendants
K090215MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009 · 3 generations on6descendants
K070131Radiforce GX220 and GS220 Monochrome LCD MonitorsEizo Nanao Corporation · 2007 · cites it directly5descendants
K130770MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013 · 4 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K000293	Barco MGD 221 2 Megapixel Diagnostic Display	Barco N.V.	2000	—
−2	K012099	Monochrome Perfectly Flat Panel Displays, ME Series	Totoku Electric Co., Ltd.	2001	—
−1	K022109	Eizo, Model FC-2091	Eizo Nanao Corporation	2002	—
0 (this device)	K041597	Monochrome LCD Monitor, Model Radiforce G22	Eizo Nanao Corporation	2004	—
+1	K061303	Medical Display, Models MDM 1900-1NG and MDM 1900-1NR	Chi Lin Technology Co., Ltd.	2006	—
+2	K063266	3MP Medical Monochrome Reference Display, Model MDM2130-3NC	Chi Lin Technology Co., Ltd.	2006	—
+3	K090215	MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TL	Nec Display Solutions, Ltd.	2009	—
+1	K070131	Radiforce GX220 and GS220 Monochrome LCD Monitors	Eizo Nanao Corporation	2007	—
+4	K130770	MD211C3 21.3 Diagnostic Imaging LCD Monitor	Nec Display Solutions, Ltd.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	3	0
2007	1	0
2009	1	0
2012	2	0
2013	1	0
2014	1	0
2015	2	0
2016	2	0
2017	1	0
2020	1	0
2025	1	0

FIG. 1 — Lineage of K041597, 2000–2025Source: 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
*	K022109	Eizo, Model FC-2091 Summary page 1 …icate Device Manufacturer : EIZO, NANAO CORPORATION Device Name : 20.8" Monochrome LCD Monitor Model Name : FC-2091 510(k) No. : K022109 8. Description of Device RadiForce 022 is a monitor for medical use. 022 provides 2 mega pixel (1200 x 1600) resolution…	Eizo Nanao Corporation	2002	—

Also cleared against K022109: 2 other devices →

What descends from it? (16)

See all 16

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

Number	Device	Applicant	Decided	Descendants
K061303	Medical Display, Models MDM 1900-1NG and MDM 1900-1NR	Chi Lin Technology Co., Ltd.	2006	9
K070131	Radiforce GX220 and GS220 Monochrome LCD Monitors	Eizo Nanao Corporation	2007	5

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 4 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K061303 (Chi Lin Technology Co., Ltd., 2006) has gone furthest, with 9 descendants of its own.
2 other devices also cite its predicate K022109.

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 G22 is intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041597: Monochrome LCD Monitor, Model Radiforce G22.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041597

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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