510(k) Report

510(k) · Cleared

Cleared

Flat Panel Displays, ME Series & CCL Series

K021738510(k) TraditionalCleared Aug 19, 200283-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 Aug 19, 2002 as substantially equivalent to K012099 (Totoku Electric Co., Ltd., 2001) after an 83-day review. Its family tree reaches back 2 generations to 2000. 28 later devices descend from it.

Decided
Aug 19, 2002
Review
83 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K000293 (2000). 28 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2011: 3 descendants cleared2006: 4 descendants cleared2010: 1 descendant cleared2014: 3 descendants cleared2004: 2 descendants cleared2005: 2 descendants cleared2015: 1 descendant cleared2017: 2 descendants cleared2016: 1 descendant cleared2008: 2 descendants cleared2007: 1 descendant cleared2018: 1 descendant cleared2024: 1 descendant cleared2022: 1 descendant cleared2013: 2 descendants cleared2021: 1 descendant clearedK000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 2000K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 7 descendants3 generations forward: 3 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001K000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 20000+5
  1. Root · 2 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. 1 generation backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. This deviceK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
  4. Descendant · cites it directly · 8 of its ownK092728 20.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd. · 2010
  5. Descendant · cites it directly · 7 of its ownK040695 21,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd. · 2004
  6. Descendant · 2 generations on · 6 of its ownK050617 21.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I &…Totoku Electric Co., Ltd. · 2005
  7. Descendant · 2 generations on · 5 of its ownK151134 21.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation · 2015
  8. Descendant · 3 generations on · 5 of its ownK063198 21.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd. · 2006

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2004: 22005: 22006: 42007: 12008: 22010: 12011: 32013: 22014: 32015: 12016: 12017: 22018: 12021: 12022: 12024: 1
2004high 4 (2006) · low 0 (2009)2026

Most influential descendants

Showing 5 of 28 · See all
  • K09272820.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd. · 2010 · cites it directly8descendants
  • K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd. · 2004 · cites it directly7descendants
  • K05061721.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HBTotoku Electric Co., Ltd. · 2005 · 2 generations on6descendants
  • K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation · 2015 · 2 generations on5descendants
  • K06319821.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd. · 2006 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
−1K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
0 (this device)K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd.2002—
+1K09272820.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd.2010—
+1K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd.2004—
+2K05061721.3-Inch (54CM) Monochrome LCD Monitor, Models MDL2109A, ME251I & DV2MM-HBTotoku Electric Co., Ltd.2005—
+2K15113421.3 inch (54cm) Color LCD Monitor CCL210 (CL21210)Jvckenwood Corporation2015—
+3K06319821.3-Inch (54CM) Monochrome LCD Monitor MDL2121A (ME253I2)Totoku Electric Co., Ltd.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
200520
200640
200710
200820
201010
201130
201320
201430
201510
201610
201720
201810
202110
202210
202410
FIG. 1 — Lineage of K021738, 2000–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—

Also cleared against K012099: 3 other devices →

What descends from it? (28)

See all 28

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

NumberDeviceApplicantDecidedDescendants
K09272820.1 Inch (51 CM) Color LCD Monitor CCL208 (CDL2013A)Totoku Electric Co., Ltd.20108
K04069521,3-Inch (54CM) Monochrome LCD Monitor ME213L (MDL2108A)Totoku Electric Co., Ltd.20047
K04069721.3-Inch (54CM) Color LCD Monitor CCL212 (CDL2107A)Totoku Electric Co., Ltd.20045
K14307620.1 inch (51cm) Monochrome LCD Monitor ME205 (ML20205)Jvckenwood Corporation20141
K06106120.1-Inch (51CM) Color LCD Monitor CDL2009A (CCL204)Tokotu Electric Co., Ltd.20061
K110108ModalixxAmpronix, Inc.20110

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 2 companies; a new generation was cleared every 1.3 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K092728 (Totoku Electric Co., Ltd., 2010) has gone furthest, with 8 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

2007: 762008: 942009: 702010: 512011: 1062012: 822013: 952014: 782015: 642016: 822017: 782018: 1042019: 742020: 812021: 832022: 652023: 872024: 622025: 582026 (partial year): 45
2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007: 36 days median2008: 52 days median2009: 62 days median2010: 98 days median2011: 79 days median2012: 87 days median2013: 84 days median2014: 89 days median2015: 90 days median2016: 90 days median2017: 107 days median2018: 105 days median2019: 107 days median2020: 115 days median2021: 116 days median2022: 137 days median2023: 157 days median2024: 131 days median2025: 173 days median2026 (partial year): 110 days median
2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007: 202008: 322009: 212010: 172011: 302012: 122013: 642014: 62015: 162016: 122017: 52018: 72019: 22020: 62021: 32022: 42023: 82024: 62025: 112026 (partial year): 14
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

2007: 1522008: 1542009: 1452010: 1452011: 4542012: 2662013: 1,1302014: 15,6312015: 2112016: 2902017: 1042018: 722019: 882020: 822021: 702022: 282023: 262024: 422025: 116
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007763620152
2008945232154
2009706221145
2010519817145
20111067930454
2012828712266
20139584641,130
20147889615,631
2015649016211
2016829012290
2017781075104
2018104105772
201974107288
202081115682
202183116370
202265137428
202387157826
202462131642
20255817311116
20264511014—

What is it indicated for?

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

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

Also cleared against K012099

3 other devices cite the same predicate.

  • K030276Flat Panel Displays, CDL SeriesTotoku Electric Co., Ltd. · 2003
  • K030272Flat Panel Display, ME183LTotoku Electric Co., Ltd. · 2003
  • K022109Eizo, Model FC-2091Eizo Nanao Corporation · 2002

More from Totoku Electric Co., Ltd.

40 FDA decisions under this applicant name. See the company

  • K11344321.3 Inch (54 CM) Monochrome LCD Monitor MS23I2 (ML21023)Totoku Electric Co., Ltd. · 2011
  • K11313621.3INCH (54CM)Color LCD Monitor CCL256I2(CL21256)Totoku Electric Co., Ltd. · 2011
  • K112145Monochrome Digital Mammography LCD Monitor MS33I2Totoku Electric Co., Ltd. · 2011
  • K11260421.3 Inch (54 CM) Color LCD Monitor CCL356I2 (CL21356)Totoku Electric Co., Ltd. · 2011
  • K11149621.3 Inch (54CM) Monochrome Digital Mammography LCD MonitorTotoku Electric Co., Ltd. · 2011

Recent decisions in LLZ

The LLZ category page

  • K261788Eden PACSHigia., Inc. d/b/a Eden · 2026
  • K261531PV-iCurve ProPerception Vision Medical Technology Co., Ltd. · 2026
  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K021738 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021738: Flat Panel Displays, ME Series & CCL Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021738

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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