510(k) · Cleared
ClearedMD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK
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 Jan 9, 2009 as substantially equivalent to K063579 (Chi Lin Technology Co., Ltd., 2006) after a 58-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jan 9, 2009
- Review
- 58 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040982 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK040982 Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation · 2004
- 2 generations backK061305 Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006
- 1 generation backK063579 2MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
- This deviceK083332 MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TKNec Display Solutions, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040982 | Color LCD Monitor, Model Radiforce R12 | Eizo Nanao Corporation | 2004 | — |
| −2 | K061305 | Medical Display, MDC1900-1LG (1LR) | Chi Lin Technology Co., Ltd. | 2006 | — |
| −1 | K063579 | 2MP Medical Color Reference Display, Model MDC2130-2HC | Chi Lin Technology Co., Ltd. | 2006 | — |
| 0 (this device) | K083332 | MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK | Nec Display Solutions, Ltd. | 2009 | — |
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 |
|---|---|---|---|
| * | K063579 | 2MP Medical Color Reference Display, Model MDC2130-2HCSummary page 1…System, Image Processing, Radiological (CLASS II CFR 4. PREDICATE DEVICE MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579). 5. DEVICE DESCRIPTION Medical Display, L218TK is a 21.3" Color LCD monitor that displays image for medical u… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K063579.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 L218TK Color display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
TheL218TK cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083332 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083332: MD21M 21.3 Diagnostic Imaging LCD Monitor, Model L218TK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083332
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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