510(k) Report

510(k) · Cleared

Cleared

Barco MWD 321 Medical Workstation Display

K972701510(k) TraditionalCleared Jan 2, 1998168-day reviewClass I21 CFR 892.2020

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Barco NV Display Systems · LMD System, Digital Image Communications, Radiological

Cleared on Jan 2, 1998 as substantially equivalent to K970999 (Sony Medical Systems, 1997) and 6 other predicates after a 168-day review. Its family tree reaches back 2 generations to 1991. 38 later devices descend from it.

Decided
Jan 2, 1998
Review
168 days
Class
Class I
Product code
LMD
Recalls
None
Predicates
7

Its longest line of descent runs back 2 generations to K913770 (1991). 14 ancestors in all, the oldest K885042 (1988). 38 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1996: 4 other ancestors1988: 1 other ancestor1995: 2 other ancestors1994: 1 other ancestor1991: 1 other ancestor1990: 2 other ancestors1998: 4 descendants cleared2004: 2 descendants cleared2002: 2 descendants 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 · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 6 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 6 descendants5 generations forward: 10 descendants6 generations forward: 5 descendants7 generations forward: 5 descendants8 generations forward: 2 descendants9 generations forward: 1 descendant K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 19910+5
  1. Root · 2 generations backK913770 Advantage V.S. CT/MR Rad Diagnostic WorkstationGeneral Electric Co. · 1991
  2. 1 generation backK960613 GE Advantage Windows Review WorkstationGE Medical Systems · 1996
  3. This deviceK972701 Barco MWD 321 Medical Workstation DisplayBarco NV Display Systems · 1998
  4. Descendant · cites it directly · 33 of its ownK980541 Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998
  5. Descendant · 2 generations on · 31 of its ownK033859 Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004
  6. Descendant · 3 generations on · 15 of its ownK042755 Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005
  7. Descendant · 3 generations on · 14 of its ownK041737 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004
  8. Descendant · 4 generations on · 13 of its ownK061447 5M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006

Showing 5 of 38 descendants. See all descendants

Descendants cleared per year

1998: 42002: 22004: 22005: 22006: 22007: 32008: 52010: 22011: 42012: 12013: 42014: 22015: 32020: 12021: 1
1998high 5 (2008) · low 0 (1999)2026

Most influential descendants

Showing 5 of 38 · See all
  • K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998 · cites it directly33descendants
  • K033859Barcoview MGD 521M Digital Mammography DisplayBarco NV Barcoview · 2004 · 2 generations on31descendants
  • K042755Monochrome LCD Monitor, Radiforce G51Eizo Nanao Corporation · 2005 · 3 generations on15descendants
  • K0417375M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A)Totoku Electric Co., Ltd. · 2004 · 3 generations on14descendants
  • K0614475M Monochrome Digital Mammography LCD Monitor MDL2116A (ME551I2)Totoku Electric Co., Ltd. · 2006 · 4 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

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

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
199840
200220
200420
200520
200620
200730
200850
201020
201140
201210
201340
201420
201530
202010
202110
FIG. 1 — Lineage of K972701, 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 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
Get a 510(k) Report

What was it cleared against? (7)

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
*K970999Sony PGM-100P1MD Trinitron Color Graphic Monitor
Summary page 1
…ical Workstation Display Classification Number: 90LMD or 74DXJ Substantial Equivalence: Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Sony Medical Systems Division, Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Aurora Technology, Aurora Diagnostic Wo…
Sony Medical Systems1997—
*K885042Sony Trinitron Color Video Monitor PVM-1343MD
Summary page 1
…: Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Sony Medical Systems Division, Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Aurora Technology, Aurora Diagnostic Workstation (K962589), ScImage, Inc., Netra Workstation System and Netra MD Software (K960…
Sony Medical Electronics Co.1988—
*K962589Aurora Diagnostic Workstation
Summary page 1
…olor Graphic Monitor (K970999), Sony Medical Systems Division, Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Aurora Technology, Aurora Diagnostic Workstation (K962589), ScImage, Inc., Netra Workstation System and Netra MD Software (K960911), Applicare Medical Imaging B.V., Radworks Medical Imagi…
Aurora Technology, Inc.1996—
*K960911Netra Workstation System & Netra MD Software
Summary page 1
…tron Color Video Monitor PVM-1343MD (K885042), Aurora Technology, Aurora Diagnostic Workstation (K962589), ScImage, Inc., Netra Workstation System and Netra MD Software (K960911), Applicare Medical Imaging B.V., Radworks Medical Imaging Software (K962699), and Accuimage, Inc., Accuimage, Inc. Image Display…
Scimage, Inc.1996—
*K962699Radworks Medical Imaging Software
Summary page 1
…nostic Workstation (K962589), ScImage, Inc., Netra Workstation System and Netra MD Software (K960911), Applicare Medical Imaging B.V., Radworks Medical Imaging Software (K962699), and Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Worksta…
Applicare Medical Imaging, B.V.1996—
*K961023Aidp (Accuimage Image Display Processor)
Summary page 1
…d Netra MD Software (K960911), Applicare Medical Imaging B.V., Radworks Medical Imaging Software (K962699), and Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. i Device Description: The MWD 321 device is…
Accuimage, Inc.1996—
*K960613GE Advantage Windows Review Workstation
Summary page 1
…Medical Imaging Software (K962699), and Accuimage, Inc., Accuimage, Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. i Device Description: The MWD 321 device is a workstation display. ' Intended Use: The Barco MWD 321 device is in…
GE Medical Systems1996—

Also cleared against K970999: 2 other devices →

What descends from it? (38)

See all 38

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

NumberDeviceApplicantDecidedDescendants
K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems199833
K982690Barco Medical Display Conformity and Consistency SoftwareBarco N.V.19982
K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray19980
K982820Barco Medis 5MP 5 Megapixel Medical Diagnostic Display SystemBarco NV Display Systems19980

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 4.3 years on median.
  • None of the 14 ancestors has a recall.
  • Of its descendants, K980541 (Barco NV Display Systems, 1998) has gone furthest, with 33 descendants of its own.
  • 2 other devices also cite its predicate K970999.

How does its category compare?

All LMD devices

LMD 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

2007: 22008: 12009: 12012: 12015: 12020: 2
2007high 2 (2007) · low 0 (2010)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMD

16in 2025

2007: 12008: 22009: 32010: 92011: 12012: 22013: 42014: 122015: 92016: 32017: 22018: 42019: 22020: 22021: 22022: 62023: 72024: 82025: 16
2007high 16 (2025) · low 1 (2007)2025

MAUDE reports naming product code LMD, 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
20070—21
20080—12
20090—13
20100—09
20110—01
20120—12
20130—04
20140—012
20150—19
20160—03
20170—02
20180—04
20190—02
20200—22
20210—02
20220—06
20230—07
20240—08
20250—016
20260—0—

What is it indicated for?

The Barco MWD 321 Medical Workstation 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.

Also cleared against K970999

2 other devices cite the same predicate.

  • K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray · 1998
  • K980541Barco MGD 521 5 Megapixel Diagnostic DisplayBarco NV Display Systems · 1998

More from Barco NV Display Systems

10 FDA decisions under this applicant name. See the company

  • K001748Medis 5MP2 Quad-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  • K001753Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  • K001750Medis 5MP1H Quad-Head Medicial Diagnostic Display SystemBarco NV Display Systems · 2000
  • K001754Medis 5MP1H Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
  • K001751Medis 2MP2 Quad-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000

Recent decisions in LMD

The LMD category page

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https://510kreport.com/device/K972701 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972701: Barco MWD 321 Medical Workstation Display.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972701

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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