uAI EasyTriage-Rib— 510(k) K193271

Name: FDA 510(k) clearance K193271
Creator: U.S. Food and Drug Administration
Published: 2021-01-15

Substantially Equivalent

Shanghai United Imaging Intelligence Co., Ltd.

FDA 510(k) clearance K193271 for uAI EasyTriage-Rib, Substantially Equivalent on 2021-01-15. Applicant: Shanghai United Imaging Intelligence Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Intelligence Co., Ltd.
Product code: Code QFM
Device class: Class 2
Regulation: 21 CFR 892.2080
Advisory panel: Radiology
Date received: 2019-11-26
Decision date: 2021-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.