# K162527: 8MP Color LCD Monitor (C81W+)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Beacon Display Technology Co., Ltd.
- Decided: Sep 30, 2016 after 21 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: 3 generations back to K103792 (2011). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152713: 8MP Color LCD Monitor, RadiForce RX850, RX850-AR, Eizo Corporation (2015) Summary page 5.

## Indications for use
The 8MP Color LCD Monitor (C81W+) is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Source page: https://510kreport.com/device/K162527
Methodology: https://510kreport.com/methodology