510(k) · Cleared
ClearedNio Color 2MP
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 Mar 25, 2014 after a 116-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 116 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK133663 Nio Color 2MPBarco N.V. · 2014
- Descendant · cites it directly · 1 of its ownK230520 Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023
- Descendant · 2 generations on · 0 of its ownK233693 Nio Color 8MP (MDNC-8132)Barco N.V. · 2023
- Descendant · cites it directly · 0 of its ownK152030 Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)Qingdao Hisense Medical Equipment Co., Ltd. · 2015
Most influential descendants
Showing 3 of 3 · See all- K230520Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521)Barco N.V. · 2023 · cites it directly1descendant
- K233693Nio Color 8MP (MDNC-8132)Barco N.V. · 2023 · 2 generations on0descendants
- K152030Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21)Qingdao Hisense Medical Equipment 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) | K133663 | Nio Color 2MP | Barco N.V. | 2014 | — |
| +1 | K230520 | Nio Color 2MP (MDNC-2521); Nio Color 3MP (MDNC-3521) | Barco N.V. | 2023 | — |
| +2 | K233693 | Nio Color 8MP (MDNC-8132) | Barco N.V. | 2023 | — |
| +1 | K152030 | Hisense 2MP/3MP LCD Monitor (HMD2C21/HMD3C21) | Qingdao Hisense Medical Equipment Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (3)
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?
- Of its descendants, K230520 (Barco N.V., 2023) has gone furthest, with 1 descendant 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. 2014, 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 2MP LED Display (MDNC-2221) 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 510(k) statement.
https://510kreport.com/device/K133663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133663: Nio Color 2MP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133663
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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