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

Shanghai United Imaging Healthcare Co.,Ltd. · K243538 · 2024-12-12

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), K243538) with a decision date of 2024-12-12. Review panel: Radiology.

FDA submission numberK243538
Pathway510(k)
CompanyShanghai United Imaging Healthcare Co.,Ltd.
Review panel (specialty)Radiology
FDA decision date2024-12-12
DecisionSubstantially Equivalent
Product codeKPS
ClassificationSystem, Tomography, Computed, Emission
Device class2
Regulation number892.1200
Review time (calendar days)27
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.