510(k) K252780

LCD Monitor (CL1902A, CL2103F) by Shenzhen Beacon Display Technology Co., Ltd. — Product Code PGY

K252780 is an FDA 510(k) premarket notification submitted by Shenzhen Beacon Display Technology Co., Ltd. for the device "LCD Monitor (CL1902A, CL2103F)". The FDA issued a decision of Substantially Equivalent on December 19, 2025. The device falls under product code PGY (Display, Diagnostic Radiology), a Class II device regulated under 21 CFR 892.2050. Shenzhen Beacon Display Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Display, Diagnostic Radiology
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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