Cleared Traditional

3MP GRAYSCAKE LCD DISPLAY

K140103 · Shenzhen Beacon Display Technology Co., Ltd. · Radiology
Feb 2014
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K140103 is an FDA 510(k) clearance for the 3MP GRAYSCAKE 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 February 14, 2014, 30 days after receiving the submission on January 15, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K140103 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 2014
Decision Date February 14, 2014
Days to Decision 30 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