Cleared Traditional

3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+

K201211 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Sep 2020

Decision

121d

Days

Class 2

Risk

About This 510(k) Submission

K201211 is an FDA 510(k) clearance for the 3MP Color LCD Monitors C32S+, C32SP+; 3MP Monochrome LCD Monitors G32S+, G32SP+, 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 September 3, 2020, 121 days after receiving the submission on May 5, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K201211 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 05, 2020
Decision Date	September 03, 2020
Days to Decision	121 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.