LCD Monitor (C1216W, C822W, C821W)

FDA 510(k) K253242 · Shenzhen Beacon Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK253242

Submission

Device name
LCD Monitor (C1216W, C822W, C821W)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
Shenzhen, CN
Received
September 29, 2025
Decision date
October 29, 2025
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PGY – Display, Diagnostic Radiology
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.

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K252030RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated Eizo Corporation08/28/2025SE
K243221RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated Eizo Corporation11/27/2024SE
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More from Acula Technology Corp.

510(k)DeviceDecision
K252780LCD Monitor (CL1902A, CL2103F)PGY · Traditional 12/19/2025SE
K2331198MP Color LCD Displays C811W, C811WT, PA27 and PA27TPZZ · Traditional 12/28/2024SE
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special 10/25/2024SE
K240310LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Traditional 03/29/2024SE
K2338975MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S…PGY · Traditional 02/06/2024SE
K23102612MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference…PGY · Traditional 08/18/2023SE
K2023744MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+PGY · Traditional 10/19/2020SE
K2012113MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+PGY · Traditional 09/03/2020SE
K2015992MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+PGY · Traditional 07/02/2020SE
K2008645MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+PGY · Traditional 05/19/2020SE

Questions and answers

When was LCD Monitor (C1216W, C822W, C821W) cleared by the FDA?

LCD Monitor (C1216W, C822W, C821W) (K253242) received a 510(k) decision of Substantially Equivalent on October 29, 2025, 30 days after the submission was received.

What is the product code of K253242?

The FDA product code is PGY – Display, Diagnostic Radiology, a Class II (moderate risk) device regulated under 21 CFR 892.2050.