Cleared Traditional

QXLINK

K132302 · Vieworks Co., Ltd. · Radiology
Sep 2013
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K132302 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. (Anaheim, US). The FDA issued a Cleared decision on September 12, 2013, 50 days after receiving the submission on July 24, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K132302 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 2013
Decision Date September 12, 2013
Days to Decision 50 days
Submission Type Traditional
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