Cleared Special

QXLink

K161113 · Vieworks Co., Ltd. · Radiology
Aug 2016
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K161113 is an FDA 510(k) clearance for the QXLink, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on August 5, 2016, 107 days after receiving the submission on April 20, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K161113 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2016
Decision Date August 05, 2016
Days to Decision 107 days
Submission Type Special
Review Panel Radiology (RA)
Summary Statement

Device Classification

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