510(k) · Cleared
ClearedCoronis 1MP Medical Flat Panel Display System
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 Dec 23, 2002 as substantially equivalent to K013922 (Barco N.V., 2002) after a 77-day review. Its family tree reaches back 2 generations to 2000. 6 later devices descend from it.
- Decided
- Dec 23, 2002
- Review
- 77 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001753 (2000). 6 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 1 generation backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- This deviceK023340 Coronis 1MP Medical Flat Panel Display SystemBarco N.V. · 2002
- Descendant · cites it directly · 1 of its ownK040310 Nova Family of Medical Radiology DisplaysNational Display Systems · 2004
- Descendant · cites it directly · 1 of its ownK033153 Dicom TheaterFerguson Medical · 2004
- Descendant · cites it directly · 0 of its ownK042353 Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems · 2004
- Descendant · 2 generations on · 0 of its ownK042942 MGP 15 Dicom TheaterBarco NV Barcoview · 2004
- Descendant · cites it directly · 0 of its ownK042634 Wide 1MP LCD Monitor SystemWide Corporation · 2004
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040310Nova Family of Medical Radiology DisplaysNational Display Systems · 2004 · cites it directly1descendant
- K033153Dicom TheaterFerguson Medical · 2004 · cites it directly1descendant
- K042353Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome DisplaysNational Display Systems · 2004 · cites it directly0descendants
- K042942MGP 15 Dicom TheaterBarco NV Barcoview · 2004 · 2 generations on0descendants
- K042634Wide 1MP LCD Monitor SystemWide Corporation · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −1 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| 0 (this device) | K023340 | Coronis 1MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| +1 | K040310 | Nova Family of Medical Radiology Displays | National Display Systems | 2004 | — |
| +1 | K033153 | Dicom Theater | Ferguson Medical | 2004 | — |
| +1 | K042353 | Axis I (1MP), II (2MP), Iii (3MP), and V (5MP) Monochrome Displays | National Display Systems | 2004 | — |
| +2 | K042942 | MGP 15 Dicom Theater | Barco NV Barcoview | 2004 | — |
| +1 | K042634 | Wide 1MP LCD Monitor System | Wide Corporation | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 6 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013922 | Coronis 3MP Medicl Flat Panel Display SystemSummary page 1…CFR 892.2050/Procode 9OLLZ Substantial Equivalence: Barco NV Display Systems Coronis 3MP Medical Flat Panel Display System (K013922) Device Description: The Coronis 1MP device is a digital image display system… | 2002 |
What descends from it? (6)
5 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 2 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K040310 (National Display Systems, 2004) has gone furthest, with 1 descendant of its own.
- 16 other devices also cite its predicate K013922.
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 Coronis 1MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023340 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023340: Coronis 1MP Medical Flat Panel Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023340
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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