# K162196: Dell UP3216Q with QUBYX PerfectLum bundle

- Pathway: 510(k) (Traditional)
- Applicant: Qubyx Software Technologies, Inc.
- Decided: Aug 15, 2016 after 10 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: 10 generations back to K000293 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150145: MD322C8 31.5 Diagnostic Imaging LCD Monitor, Nec Display Solutions, Ltd. (2015) Summary page 4.

## Indications for use
The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DELL UP3216Q 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. The device is intended for prescription use.

Source page: https://510kreport.com/device/K162196
Methodology: https://510kreport.com/methodology