510(k) · Cleared

Cleared

Monochrome Perfectly Flat Panel Displays, ME Series

K012099510(k) TraditionalCleared Jul 31, 200126-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

Totoku Electric Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Jul 31, 2001 as substantially equivalent to K000293 (Barco N.V., 2000) after a 26-day review. Its family tree reaches back 1 generation to 2000. 72 later devices descend from it.

Decided: Jul 31, 2001
Review: 26 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000293 (2000). 72 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
This deviceK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
Descendant · cites it directly · 34 of its ownK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
Descendant · cites it directly · 28 of its ownK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
Descendant · 2 generations on · 16 of its ownK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
Descendant · 2 generations on · 14 of its ownK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
Descendant · 3 generations on · 13 of its ownK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2002high 10 (2006) · low 0 (2023)2026

Most influential descendants

Showing 5 of 72 · See all

K022109Eizo, Model FC-2091Eizo Nanao Corporation · 2002 · cites it directly34descendants
K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002 · cites it directly28descendants
K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004 · 2 generations on16descendants
K052337Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005 · 2 generations on14descendants
K060845Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006 · 3 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000293	Barco MGD 221 2 Megapixel Diagnostic Display	Barco N.V.	2000	—
0 (this device)	K012099	Monochrome Perfectly Flat Panel Displays, ME Series	Totoku Electric Co., Ltd.	2001	—
+1	K022109	Eizo, Model FC-2091	Eizo Nanao Corporation	2002	—
+1	K021738	Flat Panel Displays, ME Series & CCL Series	Totoku Electric Co., Ltd.	2002	—
+2	K041597	Monochrome LCD Monitor, Model Radiforce G22	Eizo Nanao Corporation	2004	—
+2	K052337	Monochrome LCD Monitor, Model Radiforce G33	Eizo Nanao Corporation	2005	—
+3	K060845	Monochrome LCD Monitor, Radiforce Model GS310	Eizo Nanao Corporation	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0
2004	3	0
2005	5	0
2006	10	0
2007	4	0
2008	5	0
2009	1	0
2010	1	0
2011	3	0
2012	3	0
2013	4	0
2014	5	0
2015	3	0
2016	3	0
2017	3	0
2018	1	0
2019	1	0
2020	2	0
2021	1	0
2022	3	0
2024	4	0
2025	1	0

FIG. 1 — Lineage of K012099, 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
*	K000293	Barco MGD 221 2 Megapixel Diagnostic Display Our OCR of the scanned summary read K000923, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “BARCO MGD 221 2 MegaPixel Diagnostic Display”.	Barco N.V.	2000	—

Also cleared against K000293: 2 other devices →

What descends from it? (72)

See all 72

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

Number	Device	Applicant	Decided	Descendants
K022109	Eizo, Model FC-2091	Eizo Nanao Corporation	2002	34
K021738	Flat Panel Displays, ME Series & CCL Series	Totoku Electric Co., Ltd.	2002	28
K030272	Flat Panel Display, ME183L	Totoku Electric Co., Ltd.	2003	6
K030276	Flat Panel Displays, CDL Series	Totoku Electric Co., Ltd.	2003	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, K022109 (Eizo Nanao Corporation, 2002) has gone furthest, with 34 descendants of its own.
2 other devices also cite its predicate K000293.

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 ME Series Medical Displays are intended for use with Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K012099 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012099: Monochrome Perfectly Flat Panel Displays, ME Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012099

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026