510(k) Report

510(k) · Cleared

Cleared

Color LCD Monitor, Model Radiforce R12

K040982510(k) SpecialCleared May 13, 200428-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

Eizo Nanao Corporation · LLZ System, Image Processing, Radiological

Cleared on May 13, 2004 after a 28-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 15 later devices descend from it.

Decided
May 13, 2004
Review
28 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

15 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2008: 1 descendant cleared2009: 4 descendants cleared2013: 2 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2014: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK040982 Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation · 2004
  2. Descendant · cites it directly · 13 of its ownK061305 Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006
  3. Descendant · 2 generations on · 12 of its ownK063579 2MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
  4. Descendant · 3 generations on · 5 of its ownK083916 LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor…Nec Display Solutions, Ltd. · 2009
  5. Descendant · 4 generations on · 3 of its ownK111385 Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited · 2012
  6. Descendant · 4 generations on · 3 of its ownK111237 MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd. · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2006: 22008: 12009: 42011: 12012: 12013: 22014: 22017: 12020: 1
2006high 4 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 15 · See all
  • K061305Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006 · cites it directly13descendants
  • K0635792MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006 · 2 generations on12descendants
  • K083916LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TDNec Display Solutions, Ltd. · 2009 · 3 generations on5descendants
  • K111385Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited · 2012 · 4 generations on3descendants
  • K111237MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd. · 2011 · 4 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K040982Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation2004—
+1K061305Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd.2006—
+2K0635792MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd.2006—
+3K083916LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TDNec Display Solutions, Ltd.2009—
+4K111385Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited2012—
+4K111237MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TYNec Display Solutions, Ltd.2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200810
200940
201110
201210
201320
201420
201710
202010
FIG. 1 — Lineage of K040982, 2004–2020Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K061305Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd.200613
K082663Color LCD MonitorEizo Nanao Corporation20080

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?

  • Of its descendants, K061305 (Chi Lin Technology Co., Ltd., 2006) has gone furthest, with 13 descendants of its own.

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?

RadiForce R12 is intended to be used in displaying for diagnosis of X-ray or MRI, etc.

The product is not intended for use with a digital mammography system.

Indications for use as stated in the FDA 510(k) statement.

More from Eizo Nanao Corporation

34 FDA decisions under this applicant name. See the company

  • K1303365MP Monochrome LCD Monitor, Radiforce GX540Eizo Nanao Corporation · 20131 recall
  • K1300704MP Color LCD Monitor, Radiforce RX440Eizo Nanao Corporation · 2013
  • K1204518MP Color LCD Monitor, Rediforce RX840Eizo Nanao Corporation · 2012
  • K1135623MP Color LCD Monitor, Radiforce RX340Eizo Nanao Corporation · 2012
  • K1132403.7 MP Color LCD Monitor, Radiforce MX270WEizo Nanao Corporation · 2012

Recent decisions in LLZ

The LLZ category page

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  • K263048Syngo Carbon Space (VA4)Siemens Healthineers AG · 2026
  • K261874Syneris PACS v.1.0.1.0Syneris · 2026
  • K262442HipStudio AnalysisReplasia BV · 2026

https://510kreport.com/device/K040982 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040982: Color LCD Monitor, Model Radiforce R12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040982

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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