Cleared Traditional

4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+

K202374 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Oct 2020

Decision

61d

Days

Class 2

Risk

About This 510(k) Submission

K202374 is an FDA 510(k) clearance for the 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+, 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 October 19, 2020, 61 days after receiving the submission on August 19, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K202374 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2020
Decision Date	October 19, 2020
Days to Decision	61 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.