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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Image Processing Software For Radiation Therapy
510(k) Number K213155
Device Name RT-Mind-AI
Applicant
MedMind Technology Co., Ltd.
A502-503, Techart Plaza, No.30,
Xueyuan Road, Haidian District
Beijing,  CN 100083
Applicant Contact Shaobin Wang
Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number892.2050
Classification Product Code
QKB  
Date Received09/28/2021
Decision Date 12/15/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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