Cleared Traditional

2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+

K201599 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Jul 2020

Decision

20d

Days

Class 2

Risk

About This 510(k) Submission

K201599 is an FDA 510(k) clearance for the 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+, 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 July 2, 2020, 20 days after receiving the submission on June 12, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K201599 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 12, 2020
Decision Date	July 02, 2020
Days to Decision	20 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.