510(k) · Cleared
ClearedNio Fusion 4MP; MDNC 4130
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 Dec 29, 2006 as substantially equivalent to K052958 (Barcoview, 2005) after a 93-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Dec 29, 2006
- Review
- 93 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K001753 (2000). 7 ancestors in all, the oldest K000294 (2000). No later device cites it as a predicate yet.
- Root · 5 generations backK001753 Medis 5MP2 Dual-Head Medical Diagnostic Display SystemBarco NV Display Systems · 2000
- 4 generations backK013922 Coronis 3MP Medicl Flat Panel Display SystemBarco N.V. · 2002
- 3 generations backK040039 Nio 2MP Medical Grayscale Display SystemBarco N.V. · 2004
- 2 generations backK042660 Nio 2MP Medical Flat Panel Display SystemBarco NV Barcoview · 2004
- 1 generation backK052958 Color Nio 2MP, E-2320 CBarcoview · 2005
- This deviceK062905 Nio Fusion 4MP; MDNC 4130Barcoview · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K001753 | Medis 5MP2 Dual-Head Medical Diagnostic Display System | Barco NV Display Systems | 2000 | — |
| −4 | K013922 | Coronis 3MP Medicl Flat Panel Display System | Barco N.V. | 2002 | — |
| −3 | K040039 | Nio 2MP Medical Grayscale Display System | Barco N.V. | 2004 | — |
| −2 | K042660 | Nio 2MP Medical Flat Panel Display System | Barco NV Barcoview | 2004 | — |
| −1 | K052958 | Color Nio 2MP, E-2320 C | Barcoview | 2005 | — |
| 0 (this device) | 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 |
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? (1)
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 |
|---|---|---|---|
| * | K052958 | Color Nio 2MP, E-2320 CSummary page 1…sification name: System, Image Processing * Classification number: 21 CFR 892.2050 / Procode 90LLZ 5. Predicate device * Name: E-2320 C * 510(k) number: K052958 · Manufacturer: Barco NV 6. Device description MDNC 4130 is a 30" color LCD display for medical viewing. It is combined wi… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K052958.
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 Nio Fusion 4MP is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The Nio Fusion 4MP, containing the display MDNC 4130, the software MediCal QAWeb and the graphic board MXRT 2100, will be marketed as separate device.
The MDNC 4130 is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MDNC 4130, which is part of the Nio Fusion 4MP system, will be marketed separately.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062905 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062905: Nio Fusion 4MP; MDNC 4130.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062905
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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