Cleared Traditional

5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+

K200864 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

May 2020

Decision

48d

Days

Class 2

Risk

About This 510(k) Submission

K200864 is an FDA 510(k) clearance for the 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+, 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 May 19, 2020, 48 days after receiving the submission on April 1, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K200864 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 01, 2020
Decision Date	May 19, 2020
Days to Decision	48 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.