Cleared Traditional

6MP Color LCD Monitor (C61W+)

K182291 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology

Nov 2018

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K182291 is an FDA 510(k) clearance for the 6MP Color LCD Monitor (C61W+), 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 November 20, 2018, 89 days after receiving the submission on August 23, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K182291 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 2018
Decision Date	November 20, 2018
Days to Decision	89 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.