uMI Panorama— 510(k) K231572

Name: FDA 510(k) clearance K231572
Creator: U.S. Food and Drug Administration
Published: 2023-07-26

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K231572 for uMI Panorama, Substantially Equivalent on 2023-07-26. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPS
Device class: Class 2
Regulation: 21 CFR 892.1200
Advisory panel: Radiology
Date received: 2023-05-31
Decision date: 2023-07-26
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.