FDA.reportPublic FDA data

510(k) K231026

Device
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)
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
510(k) number
K231026
Product code
PGY
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-18
Date received
2023-04-11
Regulation
892.2050
Classification name
Display, Diagnostic Radiology
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Li Yafei
Address
15f, Bldg. 6, Hengda Shishang Huigu(East), Fulong Rd., Dalang Subdistrict, Longhua Shenzhen CN 518109 518109

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252780LCD Monitor (CL1902A, CL2103F)Shenzhen Beacon Display Technology Co., Ltd.2025-12-19
K253242LCD Monitor (C1216W, C822W, C821W)Shenzhen Beacon Display Technology Co., Ltd.2025-10-29
K252030RadiForce GX570; RadiForce GX570-AREizo Corporation2025-08-28
K243221RadiForce RX570; RadiForce RX570-AREizo Corporation2024-11-27
K243031LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.2024-10-25
K242008Coronis OneLookBarco N.V.2024-08-02
K2411053MP Color LCD Monitor (CL-S301)Jvckenwood Corporation2024-08-01
K241441RadiForce RX670; RadiForce RX670-AREizo Corporation2024-07-16
K24149921.3” 5MP Color LCD Display UMD5-21B01Acula Technology Corp.2024-06-13
K23333621.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)Acula Technology Corp.2024-05-21
K240310LCD Monitors C310S, G310S, C316S, G316S, C616WShenzhen Beacon Display Technology Co., Ltd.2024-03-29
K240130Medical Monitor (21HQ613D)Lg Electronics.Inc2024-02-15
K2338975MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S)Shenzhen Beacon Display Technology Co., Ltd.2024-02-06
K233465RadiForce MX317WEizo Corporation2023-12-21
K23298524HR513CLg Electronics.Inc2023-12-11