Cleared Traditional

5MP GRAYSCALE LCD DISPLAY

K132610 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology
Sep 2013
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K132610 is an FDA 510(k) clearance for the 5MP GRAYSCALE LCD DISPLAY, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on September 4, 2013, 15 days after receiving the submission on August 20, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K132610 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 2013
Decision Date September 04, 2013
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050