uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)— 510(k) K260524

Substantially Equivalent

Shanghai United Imaging Healthcare Co., Ltd.

FDA 510(k) clearance K260524 for uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), Substantially Equivalent on 2026-04-03. Applicant: Shanghai United Imaging Healthcare Co., Ltd..

Clearance details

Applicant: Shanghai United Imaging Healthcare Co., Ltd.
Product code: Code KPS
Advisory panel: Radiology
Date received: 2026-02-17
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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