510(k) · Cleared

Cleared

Eizo, Model FC-2091

K022109510(k) TraditionalCleared Jul 12, 200214-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 12, 2002 as substantially equivalent to K012099 (Totoku Electric Co., Ltd., 2001) after a 14-day review. Its family tree reaches back 2 generations to 2000. 34 later devices descend from it.

Decided: Jul 12, 2002
Review: 14 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K000293 (2000). 34 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
1 generation backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
This deviceK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
Descendant · cites it directly · 16 of its ownK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
Descendant · cites it directly · 14 of its ownK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
Descendant · 2 generations on · 13 of its ownK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
Descendant · 3 generations on · 11 of its ownK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
Descendant · 2 generations on · 9 of its ownK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2003high 5 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 34 · See all

K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004 · cites it directly16descendants
K052337Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005 · cites it directly14descendants
K060845Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006 · 2 generations on13descendants
K062053Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006 · 3 generations on11descendants
K061303Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006 · 2 generations on9descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K000293	Barco MGD 221 2 Megapixel Diagnostic Display	Barco N.V.	2000	—
−1	K012099	Monochrome Perfectly Flat Panel Displays, ME Series	Totoku Electric Co., Ltd.	2001	—
0 (this device)	K022109	Eizo, Model FC-2091	Eizo Nanao Corporation	2002	—
+1	K041597	Monochrome LCD Monitor, Model Radiforce G22	Eizo Nanao Corporation	2004	—
+1	K052337	Monochrome LCD Monitor, Model Radiforce G33	Eizo Nanao Corporation	2005	—
+2	K060845	Monochrome LCD Monitor, Radiforce Model GS310	Eizo Nanao Corporation	2006	—
+3	K062053	Monochrome LCD Monitor, Radiforce, GS320	Eizo Nanao Corporation	2006	—
+2	K061303	Medical Display, Models MDM 1900-1NG and MDM 1900-1NR	Chi Lin Technology Co., Ltd.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	1	0
2005	1	0
2006	5	0
2007	2	0
2008	1	0
2009	1	0
2012	3	0
2013	2	0
2014	2	0
2015	2	0
2016	2	0
2017	1	0
2019	1	0
2020	2	0
2022	2	0
2024	3	0
2025	1	0

FIG. 1 — Lineage of K022109, 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

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
*	K012099	Monochrome Perfectly Flat Panel Displays, ME Series Summary page 1 …RI etc. 8. Predicate Device Manufacturer: Totoku Electric Co.. Ltcl. Device name: MONOCHROME PERFECTLY FLAT PANEL DISPLAYS Model name : MESllL : ijlO(k) No.: K012099) Gray scale tones: l02ltones 9. Comparison of' technological characteristics between new device and predicate device Please…	Totoku Electric Co., Ltd.	2001	—

Also cleared against K012099: 3 other devices →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K041597	Monochrome LCD Monitor, Model Radiforce G22	Eizo Nanao Corporation	2004	16
K052337	Monochrome LCD Monitor, Model Radiforce G33	Eizo Nanao Corporation	2005	14
K024358	20.1 Monochrome LCD Monitor, Radiforce G21	Eizo Nanao Corporation	2003	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 2 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
None of the 2 ancestors has a recall.
Of its descendants, K041597 (Eizo Nanao Corporation, 2004) has gone furthest, with 16 descendants of its own.
3 other devices also cite its predicate K012099.

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?

The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of

X-ray or MRI etc.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022109 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022109: Eizo, Model FC-2091.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022109

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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