Cleared Traditional

QXLINK

K092081 · Vieworks Co., Ltd. · Radiology
Jul 2009
Decision
12d
Days
Class 2
Risk

About This 510(k) Submission

K092081 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. (Flintville, US). The FDA issued a Cleared decision on July 21, 2009, 12 days after receiving the submission on July 9, 2009. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K092081 FDA.gov
FDA Decision Cleared SESE
Date Received July 09, 2009
Decision Date July 21, 2009
Days to Decision 12 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