uPMR 790— 510(k) K234154

Name: FDA 510(k) clearance K234154
Creator: U.S. Food and Drug Administration
Published: 2024-05-24

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K234154 for uPMR 790, Substantially Equivalent on 2024-05-24. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code OUO
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2023-12-29
Decision date: 2024-05-24
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.