Emission Computed Tomography System
K-Number: K193241 · 2020-01-26
Decision Date2020-01-26
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 2020-01-26 under approval 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. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K193241.
When was Emission Computed Tomography System approved by the FDA?
Emission Computed Tomography System received FDA 510(k) clearance on 2020-01-26, under approval number K193241.
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.