# K253242: LCD Monitor (C1216W, C822W, C821W)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Beacon Display Technology Co., Ltd.
- Decided: Oct 29, 2025 after 30 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). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231026: 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models), Shenzhen Beacon Display Technology Co., Ltd. (2023) Summary page 5.
- K172815: 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+), Shenzhen Beacon Display Technology Co., Ltd. (2017) Summary page 5.
- K200864: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+, Shenzhen Beacon Display Technology Co., Ltd. (2020) Summary page 6.

## Indications for use
-- C822W This Medical Monitor is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis. -- C1216W This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners. -- C821W This Medical Monitor is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners or certified personnel. It's intended to be used in digital mammography PACS, digital breast tomosynthesis and modalities including FFDM.

Source page: https://510kreport.com/device/K253242
Methodology: https://510kreport.com/methodology