510(k) · Cleared
ClearedMD211C3 21.3 Diagnostic Imaging LCD Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nec Display Solutions, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Apr 18, 2013 as substantially equivalent to K090215 (Nec Display Solutions, Ltd., 2009) after a 29-day review. Its family tree reaches back 7 generations to 2000. 4 later devices descend from it.
- Decided
- Apr 18, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K000293 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
- 6 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
- 5 generations backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
- 4 generations backK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
- 3 generations backK061303 Medical Display, Models MDM 1900-1NG and MDM 1900-1NRChi Lin Technology Co., Ltd. · 2006
- 2 generations backK063266 3MP Medical Monochrome Reference Display, Model MDM2130-3NCChi Lin Technology Co., Ltd. · 2006
- 1 generation backK090215 MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLNec Display Solutions, Ltd. · 2009
- This deviceK130770 MD211C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
- Descendant · cites it directly · 3 of its ownK142951 MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK150145 MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK162196 Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK161057 Diagnostic Imaging Color LCD MonitorNec Display Solutions, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K142951MD210C3 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014 · cites it directly3descendants
- K150145MD322C8 31.5 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2015 · 2 generations on1descendant
- K162196Dell UP3216Q with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2016 · 3 generations on0descendants
- K161057Diagnostic Imaging Color LCD MonitorNec Display Solutions, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K000293 | Barco MGD 221 2 Megapixel Diagnostic Display | Barco N.V. | 2000 | — |
| −6 | K012099 | Monochrome Perfectly Flat Panel Displays, ME Series | Totoku Electric Co., Ltd. | 2001 | — |
| −5 | K022109 | Eizo, Model FC-2091 | Eizo Nanao Corporation | 2002 | — |
| −4 | K041597 | Monochrome LCD Monitor, Model Radiforce G22 | Eizo Nanao Corporation | 2004 | — |
| −3 | 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 | — |
| −1 | K090215 | MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TL | Nec Display Solutions, Ltd. | 2009 | — |
| 0 (this device) | K130770 | MD211C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2013 | — |
| +1 | K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2014 | — |
| +2 | K150145 | MD322C8 31.5 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2015 | — |
| +3 | K162196 | Dell UP3216Q with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | 2016 | — |
| +2 | K161057 | Diagnostic Imaging Color LCD Monitor | Nec Display Solutions, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K090215 | MD213MG 21.3 Diagnostic Imaging LCD Monitor - L218TLSummary page 1…sing, Radiological (CLASS 11CER 892.2050) 4. PREDICATE DEVICE L218TL 3MP Monochrome LCD Monitor by NEC Display Solutions Ltd. (K090215) 5. DEVICE DESCRIPTION Medical Display, MD21IIC3 is a 21.3" Color LCD monitor that displays image for medical use,… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142951 | MD210C3 21.3 Diagnostic Imaging LCD Monitor | 2014 | 3 |
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 13 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K142951 (Nec Display Solutions, Ltd., 2014) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K090215.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 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 MD21I 1C3 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.
MD21I 1C3 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC6060 1-1-1 certified equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130770: MD211C3 21.3 Diagnostic Imaging LCD Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130770
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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