510(k) · Cleared
ClearedBarco MGD 521 5 Megapixel Diagnostic Display
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco NV Display Systems · LMD System, Digital Image Communications, Radiological
Cleared on Apr 9, 1998 as substantially equivalent to K972701 (Barco NV Display Systems, 1998) and 5 other predicates after a 57-day review. Its family tree reaches back 3 generations to 1991. 33 later devices descend from it.
- Decided
- Apr 9, 1998
- Review
- 57 days
- Class
- Class I
- Product code
- LMD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K913770 (1991). 15 ancestors in all, the oldest K885042 (1988). 33 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
- 2 generations backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
- 1 generation backK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
- This deviceK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
- Descendant · cites it directly · 31 of its ownK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
- Descendant · 2 generations on · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
- Descendant · 2 generations on · 14 of its ownK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
- Descendant · 3 generations on · 13 of its ownK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006
- Descendant · 3 generations on · 6 of its ownK062054 5 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004 · cites it directly31descendants
- K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · 2 generations on15descendants
- K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004 · 2 generations on14descendants
- K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006 · 3 generations on13descendants
- K0620545 Megapixel Monochrome LCD Monitor, Radiforce GS510Eizo Nanao Corporation · 2006 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913770 | Advantage V.S. CT/MR Rad Diagnostic Workstation | General Electric Co. | 1991 | — |
| −2 | K960613 | GE Advantage Windows Review Workstation | GE Medical Systems | 1996 | — |
| −1 | K972701 | Barco MWD 321 Medical Workstation Display | Barco NV Display Systems | 1998 | — |
| 0 (this device) | K980541 | Barco MGD 521 5 Megapixel Diagnostic Display | Barco NV Display Systems | 1998 | — |
| +1 | K033859 | Barcoview MGD 521M Digital Mammography Display | Barco NV Barcoview | 2004 | — |
| +2 | K042755 | Monochrome LCD Monitor, Radiforce G51 | Eizo Nanao Corporation | 2005 | — |
| +2 | K041737 | 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) | Totoku Electric Co., Ltd. | 2004 | — |
| +3 | K061447 | 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2) | Totoku Electric Co., Ltd. | 2006 | — |
| +3 | K062054 | 5 Megapixel Monochrome LCD Monitor, Radiforce GS510 | Eizo Nanao Corporation | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 LMD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K972701 | Barco MWD 321 Medical Workstation DisplaySummary page 1…co MGD 521 5 MegaPixel Diagnostic Display 3 Classification Number: 90LMD Substantial Equivalence: Barco NV/Display Systems, Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM- 1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic… | 1998 |
| * | K970999 | Sony PGM-100P1MD Trinitron Color Graphic MonitorSummary page 1…ivalence: Barco NV/Display Systems, Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM- 1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Sclimage, Inc., Netra Workstation System and Netra MD Software (K96… | 1997 |
| * | K962589 | Aurora Diagnostic WorkstationSummary page 1…rkstation Display (K972701), Sony Medical Systems Division, Sony PGM- 1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Sclimage, Inc., Netra Workstation System and Netra MD Software (K960911), Accuimage, Inc., Accuimage, Inc. Image Display Proces… | 1996 |
| * | K960911 | Netra Workstation System & Netra MD SoftwareSummary page 1…MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Sclimage, Inc., Netra Workstation System and Netra MD Software (K960911), Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation… | 1996 |
| * | K961023 | Aidp (Accuimage Image Display Processor)Summary page 1…ora Diagnostic Workstation (K962589), Sclimage, Inc., Netra Workstation System and Netra MD Software (K960911), Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. Device Description: The MGD 521 device is a… | 1996 |
| * | K960613 | GE Advantage Windows Review WorkstationSummary page 1…System and Netra MD Software (K960911), Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. Device Description: The MGD 521 device is a diagnostic display. Intended Use: The Barco MGD 521 device is intende… | 1996 |
What descends from it? (33)
See all 332 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 7 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K033859 (Barco NV Barcoview, 2004) has gone furthest, with 31 descendants of its own.
- 3 other devices also cite its predicate K972701.
How does its category compare?
All LMD devicesLMD System, Digital Image Communications, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMD
FDA has decided no LMD device since 2007.
Median 510(k) review, days · LMD
Too few LMD 510(k)s in any year since 2007 to give a median.
Recalls per year · LMD
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMD
16in 2025
MAUDE reports naming product code LMD, 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 | 0 | — | 2 | 1 |
| 2008 | 0 | — | 1 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 2 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 1 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 2 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 16 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Barco MGD 521 5 MegaPixel Diagnostic Display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980541 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980541: Barco MGD 521 5 Megapixel Diagnostic Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980541
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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