uAI Portal
K-Number: K240411 · 2024-09-06
Decision Date2024-09-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
uAI Portal is a medical device manufactured by Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2024-09-06 under approval number K240411. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the uAI Portal?
uAI Portal is a medical device that received FDA 510(k) clearance on 2024-09-06. It is manufactured by Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K240411.
When was uAI Portal approved by the FDA?
uAI Portal received FDA 510(k) clearance on 2024-09-06, under approval number K240411.
What company makes uAI Portal?
uAI Portal is manufactured by Shanghai United Imaging Intelligence Co., Ltd..
What is the FDA product code for uAI Portal?
The FDA product code for uAI Portal is QIH.
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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.