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FDA 510(k)

uAI Portal

K-Number: K240411 · 2024-09-06

Decision Date2024-09-06
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

uAI Portal is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. It received FDA 510(k) clearance on 2024-09-06 under 510(k) 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. The listed applicant is Shanghai United Imaging Intelligence Co., Ltd.. The 510(k) number is K240411.

When did uAI Portal receive FDA 510(k) clearance?

uAI Portal received FDA 510(k) clearance on 2024-09-06, under 510(k) number K240411.

Who is the listed applicant for uAI Portal?

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

What is the FDA product code for uAI Portal?

The FDA product code for uAI Portal is QIH.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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