2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

FDA 510(k) K172815 · Shenzhen Beacon Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK172815

Submission

Device name
2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
Shenzhen, CN
Received
September 18, 2017
Decision date
October 27, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 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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K253242LCD Monitor (C1216W, C822W, C821W)PGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/29/2025SE
K252030RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated Eizo Corporation08/28/2025SE
K243221RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated Eizo Corporation11/27/2024SE
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special Shenzhen Beacon Display Technology Co., Ltd.10/25/2024SE
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More from Eizo Corporation

510(k)DeviceDecision
K252780LCD Monitor (CL1902A, CL2103F)PGY · Traditional 12/19/2025SE
K253242LCD Monitor (C1216W, C822W, C821W)PGY · Special 10/29/2025SE
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

Questions and answers

When was 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) cleared by the FDA?

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+) (K172815) received a 510(k) decision of Substantially Equivalent on October 27, 2017, 39 days after the submission was received.

What is the product code of K172815?

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