510(k) · Cleared
ClearedCoronis 3MP Medicl 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 Jan 28, 2002 as substantially equivalent to K001753 (Barco NV Display Systems, 2000) after a 62-day review. Its family tree reaches back 1 generation to 2000. 62 later devices descend from it.
- Decided
- Jan 28, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001753 (2000). 62 later devices descend from it, 17 citing it directly.
- Root · 1 generation backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- This deviceK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- Descendant · cites it directly · 25 of its ownK023322 Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002
- Descendant · cites it directly · 17 of its ownK023341 Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002
- Descendant · 2 generations on · 10 of its ownK033004 MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004
- Descendant · 2 generations on · 10 of its ownK032202 Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003
- Descendant · cites it directly · 9 of its ownK040039 Nio 2MP Medical Grayscale Display SystemBarco N.V. · 2004
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K023322Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002 · cites it directly25descendants
- K023341Cornis 5MP Medical Flat Panel Display SystemBarco N.V. · 2002 · cites it directly17descendants
- K033004MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004 · 2 generations on10descendants
- K032202Dome CX Digital Flat-Panel Display System, Models C2 and C5IPlanar Systems, Inc. · 2003 · 2 generations on10descendants
- K040039Nio 2MP Medical Grayscale Display SystemBarco N.V. · 2004 · cites it directly9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| 0 (this device) | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| +1 | K023322 | Coronis 2MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| +1 | K023341 | Cornis 5MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| +2 | K033004 | MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display | Barco NV Barcoview | 2004 | — |
| +2 | K032202 | Dome CX Digital Flat-Panel Display System, Models C2 and C5I | Planar Systems, Inc. | 2003 | — |
| +1 | K040039 | Nio 2MP Medical Grayscale Display System | Barco N.V. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 6 | 0 |
| 2004 | 16 | 0 |
| 2005 | 10 | 0 |
| 2006 | 10 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display SystemSummary page 1…s Barco Coronis 3MP Medical Flat Panel Display System 21 CFR 892.2050/Procode 90LLZ Barco NV Display Systems MeDis 5SMP2 Dual- Head Medical Diagnostic Display System (K001753) The Coronis 3MP device is a digital image display system The Barco Coronis 3MP Medical Flat Panel Display System is intended t… | 2000 |
What descends from it? (62)
See all 6217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023322 | Coronis 2MP Medical Flat Panel Display System | 2002 | 25 |
| K023341 | Cornis 5MP Medical Flat Panel Display System | 2002 | 17 |
| K040039 | Nio 2MP Medical Grayscale Display System | 2004 | 9 |
| K042221 | Coronis 5MP Medical Flat Panel Display System | 2004 | 6 |
| K032638 | Dome CX Digital Flat-Panel Display System Model, C3 Color and C3 Gray | 2003 | 6 |
| K023340 | Coronis 1MP Medical Flat Panel Display System | 2002 | 6 |
| K040041 | Nio 3MP Medical Grayscale Display System | 2004 | 3 |
| K032174 | Wide 3MP Grayscale TFT LCD Monitor IF2103A | 2003 | 2 |
| K060136 | Planar Dome EX Series Digital Flat-Panel Display System, Model E4C Color | 2006 | 1 |
| K040310 | Nova Family of Medical Radiology Displays | 2004 | 1 |
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?
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 3MP 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013922 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013922: Coronis 3MP Medicl Flat Panel Display System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013922
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026