510(k) · Cleared
ClearedBarco Medical Display Conformity and Consistency Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco N.V. · LLZ System, Image Processing, Radiological
Cleared on Oct 6, 1998 as substantially equivalent to K972701 (Barco NV Display Systems, 1998) after a 64-day review. Its family tree reaches back 3 generations to 1991. 2 later devices descend from it.
- Decided
- Oct 6, 1998
- Review
- 64 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K913770 (1991). 15 ancestors in all, the oldest K885042 (1988). 2 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 deviceK982690 Barco Medical Display Conformity and Consistency SoftwareBarco N.V. · 1998
- Descendant · cites it directly · 0 of its ownK020073 Medical AdministratorBarco N.V. · 2002
- Descendant · cites it directly · 0 of its ownK020058 Medical LEBarco N.V. · 2002
Most influential descendants
Showing 2 of 2 · See allView 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) | K982690 | Barco Medical Display Conformity and Consistency Software | Barco N.V. | 1998 | — |
| +1 | K020073 | Medical Administrator | Barco N.V. | 2002 | — |
| +1 | K020058 | Medical LE | Barco N.V. | 2002 | — |
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 |
|---|---|---|
| 2002 | 2 | 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 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 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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…ay Conformity and Consistency Software D. Classification Number: 90LMD E. Substantial Equivalence: Barco NV/Display Systems, Barco MWD 321 Medical Workstation Display (K972701), and Barco NV/Display Systems, Barco MGD 521 5 MegaPixel Diagnostic Display. F. Device Description: The MediCal device is image… | 1998 |
| * | — | Barco MGD 521 5 MegaPixel Diagnostic Display Named without a submission number |
What descends from it? (2)
2 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 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 15 ancestors has a recall.
- Of its descendants, K020073 (Barco N.V., 2002) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K972701.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
The Barco MediCal Display Conformity and Consistency Software device is intended to be used as a tool 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/K982690 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982690: Barco Medical Display Conformity and Consistency Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982690
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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