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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
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