Cleared Special

QXLink (K161113) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 Peers - LLZ System, Image Processing, Radiological

All 788
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K161113.
syngo.via MI Workflows
K163421 · Siemens Medical Solutions USA, Inc. · Jan 2017
syngo Application Software
K162541 · Siemens Medical Solutions USA, Inc. · Nov 2016
Scenium
K162339 · Siemens Medical Solutions USA, Inc. · Sep 2016
Senolris
K160937 · Ge Healthcare · Aug 2016
DICOM Viewer
K153653 · Brainlab AG · Apr 2016
Xeleris 4.0 Processing and Review Workstation
K153355 · Ge Healthcare · Mar 2016