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

Shanghai United Imaging Healthcare Co., Ltd. · K253564 · 2026-02-13

uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) is an AI-enabled medical device from Shanghai United Imaging Healthcare Co., Ltd., listed by FDA (510(k), K253564) with a decision date of 2026-02-13. Review panel: Radiology.

FDA submission numberK253564
Pathway510(k)
CompanyShanghai United Imaging Healthcare Co., Ltd.
Review panel (specialty)Radiology
FDA decision date2026-02-13
DecisionSubstantially Equivalent
Product codeKPS
ClassificationSystem, Tomography, Computed, Emission
Device class2
Regulation number892.1200
Review time (calendar days)88
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.