# K191705: OptikView GUP2103CMI

- Pathway: 510(k) (Traditional)
- Applicant: The Linden Group Corp
- Decided: Mar 16, 2020 after 264 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 K131295 (2013). 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)
- K170837: Nio Color 3MP (MDNC-3421), Barco N.V. (2017) Summary page 4.

## Indications for use
The OptikView GUP2103CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. 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 is intended for prescription use.

Source page: https://510kreport.com/device/K191705
Methodology: https://510kreport.com/methodology