uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)

Shanghai United Imaging Healthcare Co., Ltd. · K251839 · 2025-07-17

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd., listed by FDA (510(k), K251839) with a decision date of 2025-07-17. Review panel: Radiology.

FDA submission numberK251839
Pathway510(k)
CompanyShanghai United Imaging Healthcare Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2025-07-17
DecisionSubstantially Equivalent
Product codeKPS
ClassificationSystem, Tomography, Computed, Emission
Device class2
Regulation number892.1200
Review time (calendar days)31
Applicant countryCN

Official FDA database record · FDA AI-enabled device list

More devices from Shanghai United Imaging Healthcare Co., Ltd. · All Radiology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.