510(k) · Cleared
ClearedDell Ultrasharp U3011 W/Qubyx Perfectlum Bundle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Qubyx Limited · LLZ System, Image Processing, Radiological
Cleared on Jan 30, 2012 as substantially equivalent to K083916 (Nec Display Solutions, Ltd., 2009) after a 258-day review. Its family tree reaches back 4 generations to 2004. 3 later devices descend from it.
- Decided
- Jan 30, 2012
- Review
- 258 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K040982 (2004). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK040982 Color LCD Monitor, Model Radiforce R12Eizo Nanao Corporation · 2004
- 3 generations backK061305 Medical Display, MDC1900-1LG (1LR)Chi Lin Technology Co., Ltd. · 2006
- 2 generations backK063579 2MP Medical Color Reference Display, Model MDC2130-2HCChi Lin Technology Co., Ltd. · 2006
- 1 generation backK083916 LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor…Nec Display Solutions, Ltd. · 2009
- This deviceK111385 Dell Ultrasharp U3011 W/Qubyx Perfectlum BundleQubyx Limited · 2012
- Descendant · cites it directly · 2 of its ownK131601 Dell U3014 with Qubyx Perfectlum BundleQubyx Limited · 2014
- Descendant · 2 generations on · 1 of its ownK171229 DELL UP3017 with QUBYX PerfectLum bundleQubyx Software Technologies, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK200889 iMac 27 & PL 4.0Quantum-Spectra, LLC · 2020
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K040982 | Color LCD Monitor, Model Radiforce R12 | Eizo Nanao Corporation | 2004 | — |
| −3 | K061305 | Medical Display, MDC1900-1LG (1LR) | Chi Lin Technology Co., Ltd. | 2006 | — |
| −2 | K063579 | 2MP Medical Color Reference Display, Model MDC2130-2HC | Chi Lin Technology Co., Ltd. | 2006 | — |
| −1 | K083916 | LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TD | Nec Display Solutions, Ltd. | 2009 | — |
| 0 (this device) | K111385 | Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle | Qubyx Limited | 2012 | — |
| +1 | K131601 | Dell U3014 with Qubyx Perfectlum Bundle | Qubyx Limited | 2014 | — |
| +2 | K171229 | DELL UP3017 with QUBYX PerfectLum bundle | Qubyx Software Technologies, Inc. | 2017 | — |
| +3 | K200889 | iMac 27 & PL 4.0 | Quantum-Spectra, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K083916 | LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TDSummary page 1…fication Number Medical displays classified in Class 11per 21 CFR 892.2050 7. Predicate device Name: LCD3090WQXI Manufacturer: NEC Display Solutions Ltd 510O(k) number: K083916 8. Device description The DELL UltraSharp U301 1 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 4… | 2009 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131601 | Dell U3014 with Qubyx Perfectlum Bundle | 2014 | 2 |
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 8 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K131601 (Qubyx Limited, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K083916.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 DELL UltraSharp U3011 with QUBYX PerfectLum is intended to be used in displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL UllraSharp U3011 must only be used in conjunction with QUBYX PerfectLumn 3.0
These devices must not be used in primary image diagnosis in mammography.
The device can not be used for a life-support system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111385 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111385: Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111385
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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