# K160328: DIVA ZSP2105CMI with QUBYX PerfectLum bundle

- Pathway: 510(k) (Traditional)
- Applicant: The Linden Group Corp
- Decided: Feb 25, 2016 after 20 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: 2 generations back to K103792 (2011). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151883: 5MP Monochrome LCD Monitor, RadiForce GX540, Eizo Corporation (2015) Summary page 4.

## Indications for use
The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners. The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum. 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/K160328
Methodology: https://510kreport.com/methodology