510(k) · Cleared
ClearedCoronis 2MP-21 and MFGD 2621
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Barcoview · LLZ System, Image Processing, Radiological
Cleared on Sep 15, 2005 as substantially equivalent to K023322 (Barco N.V., 2002) and 1 other predicate after a 14-day review. Its family tree reaches back 4 generations to 2000. 5 later devices descend from it.
- Decided
- Sep 15, 2005
- Review
- 14 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001753 (2000). 5 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 3 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 2 generations backK023322 Coronis 2MP Medical Flat Panel Display SystemBarco N.V. · 2002
- 1 generation backK033004 MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplayBarco NV Barcoview · 2004
- This deviceK052403 Coronis 2MP-21 and MFGD 2621Barcoview · 2005
- Descendant · cites it directly · 1 of its ownK061927 Coronis Color 3MP and MDCC 3120-DLBarcoview · 2006
- Descendant · 2 generations on · 0 of its ownK080320 Primevue 21 3MP Color Display, Model AC-QX21-A9300Nds Surgical Imaging · 2008
- Descendant · cites it directly · 0 of its ownK061924 Coronis 3MP and MDCG 3120-CBBarcoview · 2006
- Descendant · cites it directly · 0 of its ownK061928 Coronis Color 2MP and MDCC 2121Barcoview · 2006
- Descendant · cites it directly · 0 of its ownK061926 Coronis 2MP and MDCG 2121 - CBBarcoview · 2006
Most influential descendants
Showing 5 of 5 · See all- K061927Coronis Color 3MP and MDCC 3120-DLBarcoview · 2006 · cites it directly1descendant
- K080320Primevue 21 3MP Color Display, Model AC-QX21-A9300Nds Surgical Imaging · 2008 · 2 generations on0descendants
- K061924Coronis 3MP and MDCG 3120-CBBarcoview · 2006 · cites it directly0descendants
- K061928Coronis Color 2MP and MDCC 2121Barcoview · 2006 · cites it directly0descendants
- K061926Coronis 2MP and MDCG 2121 - CBBarcoview · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −3 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −2 | K023322 | Coronis 2MP Medical Flat Panel Display System | Barco N.V. | 2002 | — |
| −1 | K033004 | MFGD 2320 20 Inch 2 Megapixel Greyscale LCD Display | Barco NV Barcoview | 2004 | — |
| 0 (this device) | K052403 | Coronis 2MP-21 and MFGD 2621 | Barcoview | 2005 | — |
| +1 | K061927 | Coronis Color 3MP and MDCC 3120-DL | Barcoview | 2006 | — |
| +2 | K080320 | Primevue 21 3MP Color Display, Model AC-QX21-A9300 | Nds Surgical Imaging | 2008 | — |
| +1 | K061924 | Coronis 3MP and MDCG 3120-CB | Barcoview | 2006 | — |
| +1 | K061928 | Coronis Color 2MP and MDCC 2121 | Barcoview | 2006 | — |
| +1 | K061926 | Coronis 2MP and MDCG 2121 - CB | Barcoview | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 4 | 0 |
| 2008 | 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? (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 |
|---|---|---|---|
| * | K023322 | Coronis 2MP Medical Flat Panel Display SystemSummary page 1…Classification name: System, Image Processing * Classification number: 21 CFR 892.2050 / Procode 9OLLZ 5. Predicate device * Name: Coronis 2MP * 510(k) number: K023322 • Manufacturer: Barco NV 6. Device description Coronis 2MP-21" is a display system for medical viewing. It consists of 3 com… | 2002 |
| * | K033004 | MFGD 2320 20 Inch 2 Megapixel Greyscale LCD DisplaySummary page 3…others *Classification name: System, Image Processing *Classification number: 21 CFR 892.2050 / Procode 9OLLZ 5. Predicate device * Name: MFGD 2320 * 510(k) number: K033004 * Manufacturer: Barco NV 6. Device description MFGD 2621 is a 21.3" grayscale LCD display for medical viewing. It is combine… | 2004 |
What descends from it? (5)
4 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 5 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K061927 (Barcoview, 2006) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K023322.
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 2MP-21' is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MFGD 2621 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052403 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052403: Coronis 2MP-21 and MFGD 2621.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052403
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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