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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 K243538
Device Name uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
Applicant
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Applicant Contact Gao Xin
Correspondent
Shanghai United Imaging Healthcare Co., Ltd.
#2258 Chengbei Rd. Jiading District
Shanghai,  CN 201807
Correspondent Contact Gao Xin
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received11/15/2024
Decision Date 12/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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