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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 K221706
Device Name AccuContour
Applicant
Manteia Technologies Co., Ltd.
1903, B Tower, Zijin Plaza
No. 1811 Huandao East Road
Xiamen,  CN 361001
Applicant Contact Dandan Chen
Correspondent
Manteia Technologies Co., Ltd.
1903, B Tower, Zijin Plaza
No. 1811 Huandao East Road
Xiamen,  CN 361001
Correspondent Contact Dandan Chen
Regulation Number892.2050
Classification Product Code
QKB  
Date Received06/13/2022
Decision Date 03/09/2023
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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