# K201211: 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Beacon Display Technology Co., Ltd.
- Decided: Sep 3, 2020 after 121 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: 7 generations back to K000293 (2000). 13 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182591: RadiForce RX360, RX360-AR, Eizo Corporation (2018) Summary page 5.
- K113784: 3MP Monochrome LCD Monitor, Radiforce GX340, Eizo Nanao Corporation (2012) Summary page 5.

## Most influential descendants
- K240310: LCD Monitors C310S, G310S, C316S, G316S, C616W (2024), 1 descendant of its own
- K243031: LCD Monitors C310S, G310S, C316S, G316S, C616W (2024), 0 descendants of its own
- K233336: 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) (2024), 0 descendants of its own
- K221567: LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) (2022), 0 descendants of its own

## Indications for use
The 3MP Color LCD Monitors C32S+, C32SP+ are indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The displays are not intended for mammography. The 3MP Monochrome LCD Monitors G32S+, G32SP+ are intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The devices are not specified for digital mammography systems.

Source page: https://510kreport.com/device/K201211
Methodology: https://510kreport.com/methodology