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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K253564
Device Name uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Applicant Contact Xin Gao
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Correspondent Contact Xin Gao
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/17/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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