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FDA 510(k)

uWS-CT

K-Number: K173001 · 2018-11-07

Decision Date2018-11-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uWS-CT is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-11-07 under approval number K173001. 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 uWS-CT?

uWS-CT is a medical device that received FDA 510(k) clearance on 2018-11-07. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K173001.

When was uWS-CT approved by the FDA?

uWS-CT received FDA 510(k) clearance on 2018-11-07, under approval number K173001.

What company makes uWS-CT?

uWS-CT is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for uWS-CT?

The FDA product code for uWS-CT is LLZ.

Other Devices by Shanghai United Imaging Healthcare Co., Ltd.

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Related Devices (Code: LLZ)

Official Source

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