K253564

Substantially Equivalent

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: KPS
Advisory panel: Radiology
Date received: 2025-11-17
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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