uAI Portal— 510(k) K240411

Name: FDA 510(k) clearance K240411
Creator: U.S. Food and Drug Administration
Published: 2024-09-06

Substantially Equivalent

Shanghai United Imaging Intelligence Co., Ltd.

FDA 510(k) clearance K240411 for uAI Portal, Substantially Equivalent on 2024-09-06. Applicant: Shanghai United Imaging Intelligence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Intelligence Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2024-02-12
Decision date: 2024-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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