uMI 550 PET/CT System
K-Number: K182237 · 2018-10-12
Decision Date2018-10-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uMI 550 PET/CT System is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2018-10-12 under approval number K182237. 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 uMI 550 PET/CT System?
uMI 550 PET/CT System is a medical device that received FDA 510(k) clearance on 2018-10-12. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K182237.
When was uMI 550 PET/CT System approved by the FDA?
uMI 550 PET/CT System received FDA 510(k) clearance on 2018-10-12, under approval number K182237.
What company makes uMI 550 PET/CT System?
uMI 550 PET/CT System is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uMI 550 PET/CT System?
The FDA product code for uMI 550 PET/CT System is KPS.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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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.