Cleared Special

K161113 - QXLink

K161113 is an FDA 510(k) clearance for QXLink, manufactured by Vieworks Co., Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 107-day FDA review.

K161113 · Vieworks Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
107d
Days
Class 2
Risk

K161113 is an FDA 510(k) clearance for the QXLink. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Vieworks Co., Ltd. (Anyang-Si, KR). The FDA issued a Cleared decision on August 5, 2016 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Vieworks Co., Ltd. devices

FDA 510(k) Submission Details - K161113

510(k) Number K161113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 2129
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K161113.
PACS CORE/ENCORE
K161518 · Compania Mexicana DE Radiologia Cgr, S.A. DE C.V. · Aug 2016
5D Viewer
K161955 · Samsung Medison Co., Ltd. · Aug 2016
icobrain
K161148 · Icometrix · Aug 2016
JointPoint
K160284 · Jointpoint, Inc. · Aug 2016
Senolris
K160937 · Ge Healthcare · Aug 2016
SIMPLANT Online Case Review and SIMPLANT Editor
K161118 · Dentsply Sirona · Jul 2016