510(k) · Cleared
ClearedMD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG
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 13, 2009 as substantially equivalent to K063579 (Chi Lin Technology Co., Ltd., 2006) after a 14-day review. Its family tree reaches back 3 generations to 2004. 3 later devices descend from it.
- Decided
- Jan 13, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K040982 (2004). 3 later devices descend from it, 2 citing it directly.
- 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 deviceK083907 MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TGNec Display Solutions, Ltd. · 2009
- Descendant · cites it directly · 1 of its ownK132587 MD242C2 24 Diagnostic Imaging LCD MonitorNed Display Solutions, Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK133708 MD302C4 29.8 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK130772 MD211C2 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K132587MD242C2 24 Diagnostic Imaging LCD MonitorNed Display Solutions, Ltd. · 2013 · cites it directly1descendant
- K133708MD302C4 29.8 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2014 · 2 generations on0descendants
- K130772MD211C2 21.3 Diagnostic Imaging LCD MonitorNec Display Solutions, Ltd. · 2013 · cites it directly0descendants
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) | K083907 | MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG | Nec Display Solutions, Ltd. | 2009 | — |
| +1 | K132587 | MD242C2 24 Diagnostic Imaging LCD Monitor | Ned Display Solutions, Ltd. | 2013 | — |
| +2 | K133708 | MD302C4 29.8 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2014 | — |
| +1 | K130772 | MD211C2 21.3 Diagnostic Imaging LCD Monitor | Nec Display Solutions, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 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 |
|---|---|---|---|
| * | K063579 | 2MP Medical Color Reference Display, Model MDC2130-2HCSummary page 1…ogical (CLASS 11CFR 892.2050) 4. PREDICATE DEVICE MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579). 5. DEVICE DESCRIPTION Medical Display, L21I7TG is a 21.3" Color LCD monitor that displays image for medical use.… | 2006 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K132587 (Ned Display Solutions, Ltd., 2013) has gone furthest, with 1 descendant of its own.
- 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 L217TG 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.
The L217TG cannot be used for'a life-support system.
This device must not be used in digital mammography.
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/K083907 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083907: MD212MC 21.3 Diagnostic Imaging LCD Monitor-L217TG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083907
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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