FDA 510(k)

Emission Computed Tomography System

K-Number: K193241 · 2020-01-26

ApplicantShanghai United Imaging Healthcare Co., Ltd.

Decision Date2020-01-26

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Emission Computed Tomography System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-01-26 under 510(k) number K193241. 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 2020-01-26. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193241.

When did Emission Computed Tomography System receive FDA 510(k) clearance?

Emission Computed Tomography System received FDA 510(k) clearance on 2020-01-26, under 510(k) number K193241.

Who is the listed applicant for Emission Computed Tomography System?

The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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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Other records listing Shanghai United Imaging Healthcare Co., Ltd. as applicant

K261427uMI Panvivo (uMI Panvivo M)K260113uMR Astra K253077uOmnispace.MR K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)K253173uCT 780 with uWS-CT-Dual Energy Analysis

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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.