Cleared Traditional

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

K233897 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Feb 2024

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K233897 is an FDA 510(k) clearance for the 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S), a Display, Diagnostic Radiology (Class II — Special Controls, product code PGY), submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 6, 2024, 57 days after receiving the submission on December 11, 2023. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K233897 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 11, 2023
Decision Date	February 06, 2024
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	PGY — Display, Diagnostic Radiology
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.2050
Definition	The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners.