510(k) · Cleared
ClearedColor Nio 2MP, E-2320 C
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 Nov 16, 2005 as substantially equivalent to K042660 (Barco NV Barcoview, 2004) and 1 other predicate after a 26-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.
- Decided
- Nov 16, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K001753 (2000). 6 ancestors in all, the oldest K000294 (2000). 2 later devices descend from it, 2 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 backK040039 Nio 2MP Medical Grayscale Display SystemBarco N.V. · 2004
- 1 generation backK042660 Nio 2MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- This deviceK052958 Color Nio 2MP, E-2320 CBarcoview · 2005
- Descendant · cites it directly · 0 of its ownK070726 Nio Color 3MP and MDNC 3120Barcoview, Medical Imaging Systems · 2007
- Descendant · cites it directly · 0 of its ownK062905 Nio Fusion 4MP; MDNC 4130Barcoview · 2006
Most influential descendants
Showing 2 of 2 · See allView 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 | K040039 | Nio 2MP Medical Grayscale Display System | Barco N.V. | 2004 | — |
| −1 | K042660 | Nio 2MP Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| 0 (this device) | K052958 | Color Nio 2MP, E-2320 C | Barcoview | 2005 | — |
| +1 | K070726 | Nio Color 3MP and MDNC 3120 | Barcoview, Medical Imaging Systems | 2007 | — |
| +1 | K062905 | Nio Fusion 4MP; MDNC 4130 | Barcoview | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K042660 | Nio 2MP Medical Flat Panel Display SystemSummary page 1…ocessing * Classification number: 21 CFR 892.2050 / Procode 9OLLZ S. Predicate device * Name: Nio 2MP Medical flat panel display system * 510(k) number: K042660 * Manufacturer: Barco NV 6. Device description Color Nio 2MP is a display system for medical viewing. It consists of 3 c… | 2004 |
| * | K040158 | MFCD 2320Summary page 3…ification name: System, Image Processing * Classification number: 21 CFR 892.2050 / Procode 9OLLZ 5. Predicate device · Name: MFCD 2320 * 510(k) number: K040158 * Manufacturer: Barco NV 6. Device description E-2320 C is a 20.1" color LCD display for medical viewing. It is combined… | 2004 |
What descends from it? (2)
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 5 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K070726 (Barcoview, Medical Imaging Systems, 2007) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K042660.
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 Color Nio 2MP 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 E-2320 C 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/K052958 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052958: Color Nio 2MP, E-2320 C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052958
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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