510(k) · Cleared
ClearedNio Color 3MP Led
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 29, 2013 after a 23-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.
- Decided
- May 29, 2013
- Review
- 23 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK131295 Nio Color 3MP LedBarco N.V. · 2013
- Descendant · cites it directly · 4 of its ownK170837 Nio Color 3MP (MDNC-3421)Barco N.V. · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023
- Descendant · 3 generations on · 0 of its ownK233693 Nio Color 8MP (MDNC-8132)Barco N.V. · 2023
- Descendant · 2 generations on · 0 of its ownK191705 OptikView GUP2103CMIThe Linden Group Corp · 2020
- Descendant · 2 generations on · 0 of its ownK171812 Nio Color 2MP (MDNC-2123)Barco N.V. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K170837Nio Color 3MP (MDNC-3421)Barco N.V. · 2017 · cites it directly4descendants
- K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023 · 2 generations on1descendant
- K233693Nio Color 8MP (MDNC-8132)Barco N.V. · 2023 · 3 generations on0descendants
- K191705OptikView GUP2103CMIThe Linden Group Corp · 2020 · 2 generations on0descendants
- K171812Nio Color 2MP (MDNC-2123)Barco N.V. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131295 | Nio Color 3MP Led | Barco N.V. | 2013 | — |
| +1 | K170837 | Nio Color 3MP (MDNC-3421) | Barco N.V. | 2017 | 1 |
| +2 | K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023 | — |
| +3 | K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023 | — |
| +2 | K191705 | OptikView GUP2103CMI | The Linden Group Corp | 2020 | — |
| +2 | K171812 | Nio Color 2MP (MDNC-2123) | Barco N.V. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 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? (7)
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, K170837 (Barco N.V., 2017) has gone furthest, with 4 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 Nio Color 3MP LED 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/K131295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131295: Nio Color 3MP Led.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131295
Report an extraction error
Are you the manufacturer?
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