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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, planning, radiation therapy treatment
510(k) Number K223724
Device Name MOZI TPS
Applicant
Manteia Technologies Co., Ltd.
1903-1904, B Tower, Zijin Plaza, No.1811 Huandao East Road
Xiamen,  CN 361001
Applicant Contact Chao Fang
Correspondent
Manteia Technologies Co., Ltd.
1903-1904, B Tower, Zijin Plaza, No.1811 Huandao East Road
Xiamen,  CN 361001
Correspondent Contact Chao Fang
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received12/13/2022
Decision Date 07/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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