510(k) · Cleared
ClearedCoronis 3MP
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 May 24, 2013 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- May 24, 2013
- Review
- 23 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK131246 Coronis 3MPBarco N.V. · 2013
- Descendant · cites it directly · 0 of its ownK160347 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)Qingdao Hisense Medical Equipment Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK151854 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD DisplayD-View Display Technology Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K160347Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21Qingdao Hisense Medical Equipment Co., Ltd. · 2016 · cites it directly0descendants
- K152030Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)Qingdao Hisense Medical Equipment Co., Ltd. · 2015 · cites it directly0descendants
- K1518543MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD DisplayD-View Display Technology Co., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131246 | Coronis 3MP | Barco N.V. | 2013 | — |
| +1 | K160347 | Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 | Qingdao Hisense Medical Equipment Co., Ltd. | 2016 | — |
| +1 | K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015 | — |
| +1 | K151854 | 3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display | D-View Display Technology Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 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?
- Of its descendants, K160347 (Qingdao Hisense Medical Equipment Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131246: Coronis 3MP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131246
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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