# K111385: Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle

- Pathway: 510(k) (Traditional)
- Applicant: Qubyx Limited
- Decided: Jan 30, 2012 after 258 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K040982 (2004). 4 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083916: LCD3090WQXI or MD304MC 29.8 Inch Diagnostic Imaging LCD Monitor, Model L307TD, Nec Display Solutions, Ltd. (2009) Summary page 1.

## Most influential descendants
- K131601: Dell U3014 with Qubyx Perfectlum Bundle (2014), 2 descendants of its own
- K171229: DELL UP3017 with QUBYX PerfectLum bundle (2017), 1 descendant of its own
- K200889: iMac 27 & PL 4.0 (2020), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111385
Methodology: https://510kreport.com/methodology