uEXPLORER
K-Number: K231762 · 2024-01-18
Decision Date2024-01-18
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uEXPLORER is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2024-01-18 under approval number K231762. 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 uEXPLORER?
uEXPLORER is a medical device that received FDA 510(k) clearance on 2024-01-18. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K231762.
When was uEXPLORER approved by the FDA?
uEXPLORER received FDA 510(k) clearance on 2024-01-18, under approval number K231762.
What company makes uEXPLORER?
uEXPLORER is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for uEXPLORER?
The FDA product code for uEXPLORER 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.