510(k) · Cleared
ClearedBarcoview Coronis 5MP HD Medical Flat Panel Display System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barco NV Barcoview · LLZ System, Image Processing, Radiological
Cleared on Aug 27, 2004 as substantially equivalent to K023341 (Barco N.V., 2002) after an 81-day review. Its family tree reaches back 3 generations to 2000. 4 later devices descend from it.
- Decided
- Aug 27, 2004
- Review
- 81 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001753 (2000). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 2 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 1 generation backK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
- This deviceK041508 Barcoview Coronis 5MP HD Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- Descendant · cites it directly · 2 of its ownK052312 Wide 5MP (Mammo) LCD Monitor SystemWide Corporation · 2005
- Descendant · 2 generations on · 0 of its ownK160353 MX50N (MX50YQS)Wide Corporation · 2016
- Descendant · 2 generations on · 0 of its ownK141891 Medical LCD MonitorKostec Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK043122 SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel DisplaySiemens AG · 2005
Most influential descendants
Showing 4 of 4 · See all- K052312Wide 5MP (Mammo) LCD Monitor SystemWide Corporation · 2005 · cites it directly2descendants
- K160353MX50N (MX50YQS)Wide Corporation · 2016 · 2 generations on0descendants
- K141891Medical LCD MonitorKostec Co., Ltd. · 2014 · 2 generations on0descendants
- K043122SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel DisplaySiemens AG · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −2 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −1 | K023341 | Cornis 5MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| 0 (this device) | K041508 | Barcoview Coronis 5MP HD Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| +1 | K052312 | Wide 5MP (Mammo) LCD Monitor System | Wide Corporation | 2005 | — |
| +2 | K160353 | MX50N (MX50YQS) | Wide Corporation | 2016 | — |
| +2 | K141891 | Medical LCD Monitor | Kostec Co., Ltd. | 2014 | — |
| +1 | K043122 | SMD 21500 or DSB-2103-D-5MP-5M Pixel Grayscale Flat Panel Display | Siemens AG | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 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 |
|---|---|---|---|
| * | K023341 | Cornis 5MP Medical Flat Panel Display System | 2002 |
What descends from it? (4)
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 4 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K052312 (Wide Corporation, 2005) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K023341.
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 5MP HD display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041508 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041508: Barcoview Coronis 5MP HD Medical Flat Panel Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041508
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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