510(k) Report

510(k) · Cleared

Cleared

Barco MGD 221 2 Megapixel Diagnostic Display

K000293510(k) TraditionalCleared Mar 29, 200058-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

Barco N.V. · LLZ System, Image Processing, Radiological

Cleared on Mar 29, 2000 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 75 later devices descend from it.

Decided
Mar 29, 2000
Review
58 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
0

75 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2004: 5 descendants cleared2003: 4 descendants cleared2002: 2 descendants cleared2011: 3 descendants cleared2006: 10 descendants cleared2010: 1 descendant cleared2014: 5 descendants cleared2005: 5 descendants cleared2007: 4 descendants cleared2008: 5 descendants cleared2015: 3 descendants cleared2017: 3 descendants cleared2013: 4 descendants cleared2012: 3 descendants cleared2016: 3 descendants cleared2009: 1 descendant cleared2020: 2 descendants cleared2018: 1 descendant cleared2025: 1 descendant cleared2024: 4 descendants cleared2022: 3 descendants cleared2019: 1 descendant cleared2021: 1 descendant cleared200020052010201520202025
  1. This deviceK000293 Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V. · 2000
  2. Descendant · cites it directly · 72 of its ownK012099 Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001
  3. Descendant · 2 generations on · 34 of its ownK022109 Eizo, Model FC-2091Eizo Nanao Corporation · 2002
  4. Descendant · 2 generations on · 28 of its ownK021738 Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002
  5. Descendant · 3 generations on · 16 of its ownK041597 Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004
  6. Descendant · 3 generations on · 14 of its ownK052337 Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2001: 12002: 22003: 42004: 52005: 52006: 102007: 42008: 52009: 12010: 12011: 32012: 32013: 42014: 52015: 32016: 32017: 32018: 12019: 12020: 22021: 12022: 32024: 42025: 1
2001high 10 (2006) · low 0 (2023)2026

Most influential descendants

Showing 5 of 75 · See all
  • K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd. · 2001 · cites it directly72descendants
  • K022109Eizo, Model FC-2091Eizo Nanao Corporation · 2002 · 2 generations on34descendants
  • K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd. · 2002 · 2 generations on28descendants
  • K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation · 2004 · 3 generations on16descendants
  • K052337Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation · 2005 · 3 generations on14descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000293Barco MGD 221 2 Megapixel Diagnostic DisplayBarco N.V.2000—
+1K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.2001—
+2K022109Eizo, Model FC-2091Eizo Nanao Corporation2002—
+2K021738Flat Panel Displays, ME Series & CCL SeriesTotoku Electric Co., Ltd.2002—
+3K041597Monochrome LCD Monitor, Model Radiforce G22Eizo Nanao Corporation2004—
+3K052337Monochrome LCD Monitor, Model Radiforce G33Eizo Nanao Corporation2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200220
200340
200450
200550
2006100
200740
200850
200910
201010
201130
201230
201340
201450
201530
201630
201730
201810
201910
202020
202110
202230
202440
202510
FIG. 1 — Lineage of K000293, 2000–2025Source: 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), 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (75)

See all 75

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

NumberDeviceApplicantDecidedDescendants
K012099Monochrome Perfectly Flat Panel Displays, ME SeriesTotoku Electric Co., Ltd.200172
K033104MGD 2621P Medical Greyscale DisplayBarco NV Barcoview20040
K033103MGD 2621L Medical Greyscale DisplayBarco NV Barcoview20040

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, K012099 (Totoku Electric Co., Ltd., 2001) has gone furthest, with 72 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—
Cite this page

510(k) Report. “K000293: Barco MGD 221 2 Megapixel Diagnostic Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K000293

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026