uAI Easy Triage ICH— 510(k) K242292

Name: FDA 510(k) clearance K242292
Creator: U.S. Food and Drug Administration
Published: 2024-09-24

Substantially Equivalent

Shanghai United Imaging Intelligence Co., Ltd.

FDA 510(k) clearance K242292 for uAI Easy Triage ICH, Substantially Equivalent on 2024-09-24. Applicant: Shanghai United Imaging Intelligence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Intelligence Co., Ltd.
Product code: Code QAS
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2024-08-02
Decision date: 2024-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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