510(k) Report

510(k) · Cleared

Cleared

Data Ray Corporation DR11021 Medical Imaging Monitor

K983392510(k) TraditionalCleared Dec 15, 199881-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

Data Ray · LLZ System, Image Processing, Radiological

Cleared on Dec 15, 1998 as substantially equivalent to K980541 (Barco NV Display Systems, 1998) and 5 other predicates after an 81-day review. Its family tree reaches back 4 generations to 1991.

Decided
Dec 15, 1998
Review
81 days
Class
Class II
Product code
LLZ
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K913770 (1991). 16 ancestors in all, the oldest K885042 (1988). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 4 other ancestors1995: 2 other ancestors1994: 1 other ancestor1990: 2 other ancestors1988: 1 other ancestor1991: 1 other ancestorK913770 · Advantage V.S. CT/MR Rad Diagnostic Workstation · General Electric Co. · 1991K960613 · GE Advantage Windows Review Workstation · GE Medical Systems · 1996K972701 · Barco MWD 321 Medical Workstation Display · Barco NV Display Systems · 1998K980541 · Barco MGD 521 5 Megapixel Diagnostic Display · Barco NV Display Systems · 19981985199019952000
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 3 other ancestors 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
  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 deviceK983392 Data Ray Corporation DR11021 Medical Imaging MonitorData Ray · 1998
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)K983392Data Ray Corporation DR11021 Medical Imaging MonitorData Ray1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199020
199110
199410
199520
199640
199710
FIG. 1 — Lineage of K983392, 1991–1998Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K980541Barco MGD 521 5 Megapixel Diagnostic Display
Summary page 1
…Name: DR11021 Medical Imaging Monitor Classification Number: 90 LMD Substantially Equivilant To: Barco NV/Display Systems, Barco MGD 521 5 Megapixel Diagnostic Display (K980541), Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Mon…
Barco NV Display Systems1998—
*K972701Barco MWD 321 Medical Workstation Display
Summary page 1
…Number: 90 LMD Substantially Equivilant To: Barco NV/Display Systems, Barco MGD 521 5 Megapixel Diagnostic Display (K980541), Barco MWD 321 Medical Workstation Display (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic…
Barco NV Display Systems1998—
*K970999Sony PGM-100P1MD Trinitron Color Graphic Monitor
Summary page 1
…apixel Diagnostic Display (K980541), 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), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), G…
Sony Medical Systems1997—
*K962589Aurora Diagnostic Workstation
Summary page 1
…orkstation Display (K972701), Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (…
Aurora Technology, Inc.1996—
*K961023Aidp (Accuimage Image Display Processor)
Summary page 1
…PGM-1001MD Trinitron Color Graphic Monitor (K970999), Aurora Technology, Aurora Diagnostic Workstation (K962589), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. Device Description: The DR11021 Medical Ima…
Accuimage, Inc.1996—
*K960613GE Advantage Windows Review Workstation
Summary page 1
…, Aurora Diagnostic Workstation (K962589), Accuimage Inc., Accuimage Inc. Image Display Processor (K961023), GE Medical Systems, GE Advantage Windows Review Workstation (K960613), and others. Device Description: The DR11021 Medical Imaging Monitor is a diagnostic display used in- film-less radiology appli…
GE Medical Systems1996—

Also cleared against K980541: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 4 companies; a new generation was cleared every 1.7 years on median.
  • None of the 16 ancestors has a recall.
  • 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 Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless

radiology systems to display digitized x-ray images. These digitized x-ray images are

viewed by trained medical providers for the purpose of diagnosing and/or treating

illnesses in human beings.

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 K980541

1 other device cites the same predicate.

  • K033859Barcoview MGD 521M Digital Mammography DisplayBarco 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/K983392 · printed Nov 4, 2026

Cite this page

510(k) Report. “K983392: Data Ray Corporation DR11021 Medical Imaging Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983392

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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