510(k) Report

510(k) · Cleared

Cleared

3MP Medical Monochrome Reference Display, Model MDM2130-3NC

K063266510(k) TraditionalCleared Nov 9, 200610-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

Chi Lin Technology Co., Ltd. · LLZ System, Image Processing, Radiological

Cleared on Nov 9, 2006 as substantially equivalent to K061303 (Chi Lin Technology Co., Ltd., 2006) after a 10-day review. Its family tree reaches back 5 generations to 2000. 7 later devices descend from it.

Decided
Nov 9, 2006
Review
10 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K000293 (2000). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 1 descendant cleared2013: 1 descendant cleared2014: 1 descendant cleared2015: 1 descendant cleared2016: 2 descendants clearedK000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 2000K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001K022109 · Eizo, Model FC-2091 · Eizo Nanao Corporation · 2002K041597 · Monochrome LCD Monitor, Model Radiforce G22 · Eizo Nanao Corporation · 2004K061303 · Medical Display, Models MDM 1900-1NG and MDM 1900-1NR · Chi Lin Technology Co., Ltd. · 2006200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants5 generations forward: 1 descendant K061303 · Medical Display, Models MDM 1900-1NG and MDM 1900-1NR · Chi Lin Technology Co., Ltd. · 2006K041597 · Monochrome LCD Monitor, Model Radiforce G22 · Eizo Nanao Corporation · 2004K022109 · Eizo, Model FC-2091 · Eizo Nanao Corporation · 2002K012099 · Monochrome Perfectly Flat Panel Displays, ME Series · Totoku Electric Co., Ltd. · 2001K000293 · Barco MGD 221 2 Megapixel Diagnostic Display · Barco N.V. · 2000−50+5
  1. Root · 5 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. 4 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. 3 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
  4. 2 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
  5. 1 generation backK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
  6. This deviceK063266 3MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006
  7. Descendant · cites it directly · 6 of its ownK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
  8. Descendant · 2 generations on · 4 of its ownK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
  9. Descendant · 3 generations on · 3 of its ownK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
  10. Descendant · 4 generations on · 1 of its ownK150145 MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015
  11. Descendant · 5 generations on · 0 of its ownK162196 Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12012: 12013: 12014: 12015: 12016: 2
2009high 2 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K090215MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009 · cites it directly6descendants
  • K130770MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013 · 2 generations on4descendants
  • K142951MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014 · 3 generations on3descendants
  • K150145MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015 · 4 generations on1descendant
  • K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016 · 5 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
−4K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
−3K022109Eizo, Model FC-2091Eizo Nanao Corporation2002—
−2K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation2004—
−1K061303Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd.2006—
0 (this device)K0632663MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd.2006—
+1K090215MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd.2009—
+2K130770MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd.2013—
+3K142951MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd.2014—
+4K150145MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd.2015—
+5K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201310
201410
201510
201620
FIG. 1 — Lineage of K063266, 2000–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
*K061303Medical Display, Models MDM 1900-1NG and MDM 1900-1NR
Summary page 1
…Radiological (CLASS 1I CFR 892.2050) 4. PREDICATE DEVICE Medical Display - MDMI900-1NR 19" Monochrome LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061303). 5. DEVICE DESCRIPTION Medical Display, MDM2130-3NC is a 21.3" monochrome LCD monitor that displays image for m…
Chi Lin Technology Co., Ltd.2006—

Also cleared against K061303: 1 other device →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090215MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd.20096

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 4 companies; a new generation was cleared every 1.3 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K090215 (Nec Display Solutions, Ltd., 2009) has gone furthest, with 6 descendants of its own.
  • 1 other device also cites its predicate K061303.

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?

3MP Medical Monochrome Reference Display,

MDM2130-3NC is intended to use in displaying images for review and analysis by

trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is

not suitable for a digital mammography system.

Indications for use as stated in the FDA summary.

Also cleared against K061303

1 other device cites the same predicate.

  • K0632892MP Medical Monochrome Reference Display, Model MDM2130-2NCChi Lin Technology Co., Ltd. · 2006

More from Chi Lin Technology Co., Ltd.

6 FDA decisions under this applicant name. See the company

  • K0632695MP Medical Monochrome Reference Display, Model MDM2010-5NCChi Lin Technology Co., Ltd. · 2007
  • K0635792MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
  • K0632892MP Medical Monochrome Reference Display, Model MDM2130-2NCChi Lin Technology Co., Ltd. · 2006
  • K061303Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
  • K061305Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006

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/K063266 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063266: 3MP Medical Monochrome Reference Display, Model MDM2130-3NC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063266

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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