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FDA 510(k)

Emission Computed Tomography System

K-Number: K182938 · 2018-12-18

ApplicantShanghai United Imaging Healthcare Co., Ltd.
Decision Date2018-12-18
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Emission Computed Tomography System is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-12-18 under approval number K182938. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Emission Computed Tomography System?

Emission Computed Tomography System is a medical device that received FDA 510(k) clearance on 2018-12-18. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K182938.

When was Emission Computed Tomography System approved by the FDA?

Emission Computed Tomography System received FDA 510(k) clearance on 2018-12-18, under approval number K182938.

What company makes Emission Computed Tomography System?

Emission Computed Tomography System is manufactured by Shanghai United Imaging Healthcare Co., Ltd..

What is the FDA product code for Emission Computed Tomography System?

The FDA product code for Emission Computed Tomography System is KPS.

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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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