510(k) Report

510(k) · Cleared

Cleared

Monochrome LCD Monitor, Model Radiforce G33

K052337510(k) SpecialCleared Sep 8, 200513-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 Sep 8, 2005 as substantially equivalent to K022109 (Eizo Nanao Corporation, 2002) after a 13-day review. Its family tree reaches back 3 generations to 2000. 14 later devices descend from it.

Decided
Sep 8, 2005
Review
13 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K000293 (2000). 14 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 2 descendants cleared2013: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2012: 1 descendant cleared2014: 1 descendant cleared2020: 1 descendant cleared2022: 2 descendants cleared2019: 1 descendant cleared2024: 3 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 · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 5 descendants6 generations forward: 1 descendant K022109 · 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. · 20000+5
  1. Root · 3 generations backK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. 2 generations backK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. 1 generation backK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
  4. This deviceK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005
  5. Descendant · cites it directly · 13 of its ownK060845 Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006
  6. Descendant · 2 generations on · 11 of its ownK062053 Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006
  7. Descendant · 3 generations on · 8 of its ownK113784 3MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012
  8. Descendant · 4 generations on · 4 of its ownK201211 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors…Shenzhen Beacon Display Technology Co., Ltd. · 2020
  9. Descendant · 4 generations on · 2 of its ownK141690 Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2006: 22007: 12008: 12012: 12013: 12014: 12019: 12020: 12022: 22024: 3
2006high 3 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 14 · See all
  • K060845Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation · 2006 · cites it directly13descendants
  • K062053Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation · 2006 · 2 generations on11descendants
  • K1137843MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation · 2012 · 3 generations on8descendants
  • K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd. · 2020 · 4 generations on4descendants
  • K141690Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd. · 2014 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
−2K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
−1K022109Eizo, Model FC-2091Eizo Nanao Corporation2002—
0 (this device)K052337Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation2005—
+1K060845Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation2006—
+2K062053Monochrome LCD Monitor, Radiforce, GS320Eizo Nanao Corporation2006—
+3K1137843MP Monochrome LCD Monitor, Radiforce GX340Eizo Nanao Corporation2012—
+4K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+Shenzhen Beacon Display Technology Co., Ltd.2020—
+4K141690Jusha-M33C LCD MonitorNanjing Jusha Display Technology Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200620
200710
200810
201210
201310
201410
201910
202010
202220
202430
FIG. 1 — Lineage of K052337, 2000–2024Source: 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
*K022109Eizo, Model FC-2091
Summary page 1
…92.2050. 7. Predicate Device Manufacturer :EIZO NANAO CORPORATION Device Name :20.8" Monochrome LCD Monitor Model Name :FC-2091 510(k) No. :K022109 8. Description of Device RadiForce 033 is a 53cm (20.8") -4imy LCD display for medical viewing. 033 displays high-de…
Eizo Nanao Corporation2002—

Also cleared against K022109: 2 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K060845Monochrome LCD Monitor, Radiforce Model GS310Eizo Nanao Corporation200613

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 1.3 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K060845 (Eizo Nanao Corporation, 2006) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K022109.

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 G33 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices must not be used for digital mammography system.

Indications for use as stated in the FDA summary.

Also cleared against K022109

2 other devices cite the same predicate.

  • K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
  • K02435820.1 Monochrome LCD Monitor, Radiforce G21Eizo Nanao Corporation · 2003

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

  • 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/K052337 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052337: Monochrome LCD Monitor, Model Radiforce G33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052337

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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