510(k) Report

510(k) · Cleared

Cleared

Barcoview MGD 521M Digital Mammography Display

K033859510(k) TraditionalCleared Jun 2, 2004174-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 NV Barcoview · LLZ System, Image Processing, Radiological

Cleared on Jun 2, 2004 as substantially equivalent to K980541 (Barco NV Display Systems, 1998) after a 174-day review. Its family tree reaches back 4 generations to 1991. 31 later devices descend from it.

Decided
Jun 2, 2004
Review
174 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K913770 (1991). 16 ancestors in all, the oldest K885042 (1988). 31 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 4 other ancestors1995: 2 other ancestors1994: 1 other ancestor1990: 2 other ancestors1988: 1 other ancestor1991: 1 other ancestor2004: 1 descendant cleared2005: 2 descendants cleared2006: 2 descendants cleared2013: 4 descendants cleared2007: 3 descendants cleared2011: 4 descendants cleared2008: 5 descendants cleared2010: 2 descendants cleared2015: 3 descendants cleared2012: 1 descendant cleared2014: 2 descendants cleared2020: 1 descendant cleared2021: 1 descendant clearedK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996×2: 2 generations cleared close together, K972701 (1998), K980541 (1998) 1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors3 generations back: 6 other ancestors4 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 6 descendants3 generations forward: 10 descendants4 generations forward: 5 descendants5 generations forward: 5 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K980541 · Barco MGD 521 5 Megapixel Diagnostic Display · Barco NV Display Systems · 1998K972701 · Barco MWD 321 Medical Workstation Display · Barco NV Display Systems · 1998K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 19910+5
  1. Root · 4 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 3 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. 2 generations backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
  4. 1 generation backK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
  5. This deviceK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
  6. Descendant · cites it directly · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
  7. Descendant · cites it directly · 14 of its ownK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
  8. Descendant · 2 generations on · 13 of its ownK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006
  9. Descendant · 2 generations on · 6 of its ownK062054 5 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006
  10. Descendant · 3 generations on · 4 of its ownK081242 21.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2…Tokotu Electric Co., Ltd. · 2008

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 22007: 32008: 52010: 22011: 42012: 12013: 42014: 22015: 32020: 12021: 1
2004high 5 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 31 · See all
  • K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · cites it directly15descendants
  • K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004 · cites it directly14descendants
  • K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006 · 2 generations on13descendants
  • K0620545 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006 · 2 generations on6descendants
  • K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd. · 2008 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K913770Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co.1991—
−3K960613GE Advantage Windows Review WorkstationGE Medical Systems1996—
−2K972701Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems1998—
−1K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems1998—
0 (this device)K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview2004—
+1K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation2005—
+1K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.2004—
+2K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd.2006—
+2K0620545 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation2006—
+3K08124221.3 Inch (53CM) Monochrome Digital Mammography LCD Monitor MS51I2, (MDL2123A)Tokotu Electric Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199020
199110
199410
199520
199640
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200620
200730
200850
201020
201140
201210
201340
201420
201530
202010
202110
FIG. 1 — Lineage of K033859, 1991–2021Source: 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 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
*K980541Barco MGD 521 5 Megapixel Diagnostic Display
Summary page 1
…892.2050/Procode 9OLLZ Substantial Equivalence: Barco NV Display Systems MGD 521 5 Megapixel Diagnostic Display (K980541) Device Description: The MGD 521M device is a digital image display Intended Use:…
Barco NV Display Systems1998—

Also cleared against K980541: 1 other device →

What descends from it? (31)

See all 31

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

NumberDeviceApplicantDecidedDescendants
K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation200515
K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd.200414

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 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
  • None of the 16 ancestors has a recall.
  • Of its descendants, K042755 (Eizo Nanao Corporation, 2005) has gone furthest, with 15 descendants of its own.
  • 1 other device also cites its predicate K980541.

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?

The MGD 521M display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically intended for use with any digital mammography system for which the MGD 521M device meets the criteria specified by the manufacturer of the digital mammography system.

Indications for use as stated in the FDA summary.

Also cleared against K980541

1 other device cites the same predicate.

  • K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray · 1998

More from Barco NV Barcoview

14 FDA decisions under this applicant name. See the company

  • K042221Coronis 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042942MGP 15 Dicom TheaterBarco NV Barcoview · 2004
  • K042662Nio 5MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042661Nio 3MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
  • K042660Nio 2MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004

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/K033859 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033859: Barcoview MGD 521M Digital Mammography Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033859

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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