uOmnispace.MR— 510(k) K253077

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..

Clearance details

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

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