Cleared Traditional

2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+)

K172815 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Oct 2017

Decision

39d

Days

Class 2

Risk

About This 510(k) Submission

K172815 is an FDA 510(k) clearance for the 2MP LCD Monitor (G22S+, G22SP+, C22S+, C22SP+), 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 27, 2017, 39 days after receiving the submission on September 18, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K172815 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2017
Decision Date	October 27, 2017
Days to Decision	39 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.