Cleared Traditional

8MP Color LCD Monitor (C81W+)

K162527 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Sep 2016

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K162527 is an FDA 510(k) clearance for the 8MP Color LCD Monitor (C81W+), 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 30, 2016, 21 days after receiving the submission on September 9, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K162527 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 09, 2016
Decision Date	September 30, 2016
Days to Decision	21 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.