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FDA 510(k)

QXLink

K-Number: K161113 · 2016-08-05

ApplicantVieworks Co., Ltd.
Decision Date2016-08-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QXLink is a medical device manufactured by Vieworks Co., Ltd.. It received FDA 510(k) clearance on 2016-08-05 under approval number K161113. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QXLink?

QXLink is a medical device that received FDA 510(k) clearance on 2016-08-05. It is manufactured by Vieworks Co., Ltd.. The 510(k) number is K161113.

When was QXLink approved by the FDA?

QXLink received FDA 510(k) clearance on 2016-08-05, under approval number K161113.

What company makes QXLink?

QXLink is manufactured by Vieworks Co., Ltd..

What is the FDA product code for QXLink?

The FDA product code for QXLink is LLZ.

Other Devices by Vieworks Co., Ltd.

K152894VIVIX-S 1717N K152855VIVIX-S 1012N K163703VIVIX-S 1417N K181003VIVIX-S 1717V K190611VIVIX-S 1751S K200418VIVIX-S VW

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Related Devices (Code: LLZ)

K161959ClearView cCADClearview Diagnostics, Inc. K163539Ez3D-i / E3Ewoosoft Co., Ltd. K162955Multi-Modality Tumor Tracking (MMTT) applicationPhilips Medical Systems Nederland B.V. K160852ZiaZetta Medical Technologies, LLC K162376CAAS MR 4D FlowPie Medical Imaging BV K161322CT CoPilotZepmed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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