5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)

Q: What is the product code of K233897?

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

FDA 510(k) K233897 · Shenzhen Beacon Display Technology Co., Ltd.

Substantially Equivalent

510(k) numberK233897

Submission

Device name: 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)
Applicant: Shenzhen Beacon Display Technology Co., Ltd.
Shenzhen, CN
Received: December 11, 2023
Decision date: February 6, 2024
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.

Other 510(k)s with product code PGY

510(k)	Device	Applicant	Decision
K262783	RadiForce MX247WPGY · Abbreviated	Eizo Corporation	09/01/2026SE
K261213	Medical Monitor (40HT513D)PGY · Traditional	Lg Electronics.Inc	06/12/2026SE
K252780	LCD Monitor (CL1902A, CL2103F)PGY · Traditional	Shenzhen Beacon Display Technology Co., Ltd.	12/19/2025SE
K253242	LCD Monitor (C1216W, C822W, C821W)PGY · Special	Shenzhen Beacon Display Technology Co., Ltd.	10/29/2025SE
K252030	RadiForce GX570; RadiForce GX570-ARPGY · Abbreviated	Eizo Corporation	08/28/2025SE
K243221	RadiForce RX570; RadiForce RX570-ARPGY · Abbreviated	Eizo Corporation	11/27/2024SE
K243031	LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special	Shenzhen Beacon Display Technology Co., Ltd.	10/25/2024SE
K242008	Coronis OneLookPGY · Special	Barco N.V.	08/02/2024SE
K241105	3MP Color LCD Monitor (CL-S301)PGY · Traditional	Jvckenwood Corporation	08/01/2024SE
K241441	RadiForce RX670; RadiForce RX670-ARPGY · Abbreviated	Eizo Corporation	07/16/2024SE

More from Eizo Corporation

510(k)	Device	Decision
K252780	LCD Monitor (CL1902A, CL2103F)PGY · Traditional	12/19/2025SE
K253242	LCD Monitor (C1216W, C822W, C821W)PGY · Special	10/29/2025SE
K233119	8MP Color LCD Displays C811W, C811WT, PA27 and PA27TPZZ · Traditional	12/28/2024SE
K243031	LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Special	10/25/2024SE
K240310	LCD Monitors C310S, G310S, C316S, G316S, C616WPGY · Traditional	03/29/2024SE
K231026	12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference…PGY · Traditional	08/18/2023SE
K202374	4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+PGY · Traditional	10/19/2020SE
K201211	3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+PGY · Traditional	09/03/2020SE
K201599	2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+PGY · Traditional	07/02/2020SE
K200864	5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+PGY · Traditional	05/19/2020SE

Questions and answers

When was 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) cleared by the FDA?

5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) (K233897) received a 510(k) decision of Substantially Equivalent on February 6, 2024, 57 days after the submission was received.

What is the product code of K233897?

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