uOmnispace.MR— 510(k) K253077

Name: FDA 510(k) clearance K253077
Creator: U.S. Food and Drug Administration
Published: 2026-04-22

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K253077 for uOmnispace.MR, Substantially Equivalent on 2026-04-22. Applicant: Shanghai United Imaging Healthcare Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code QIH
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-09-23
Decision date: 2026-04-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Shanghai United Imaging Healthcare Co., Ltd.

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