# K131601: Dell U3014 with Qubyx Perfectlum Bundle

- Pathway: 510(k) (Traditional)
- Applicant: Qubyx Limited
- Decided: Jul 7, 2014 after 399 days
- Product code: PGY (Display, Diagnostic Radiology)
- 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: 5 generations back to K040982 (2004). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111385: Dell Ultrasharp U3011 W/Qubyx Perfectlum Bundle, Qubyx Limited (2012) Summary page 1.
- K111237: MD301C4 29.8 Diagnostic Imaging LCD Monitor, L309TY, Nec Display Solutions, Ltd. (2011) Summary page 1.

## Most influential descendants
- 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 U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DELL U3014 can be used only in conjunction with QUBYX PerfectLum. The device can not be used in primary image diagnosis in mammography. The device can not be used for a life-support system. The device does not contact with the patient.

Source page: https://510kreport.com/device/K131601
Methodology: https://510kreport.com/methodology