Cleared Traditional

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

K253564 · Shanghai United Imaging Healthcare Co., Ltd. · Radiology

Feb 2026

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K253564 is an FDA 510(k) clearance for the uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES), a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by Shanghai United Imaging Healthcare Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 13, 2026, 88 days after receiving the submission on November 17, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number	K253564 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2025
Decision Date	February 13, 2026
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF