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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 K191928
Device Name AccuContour
Applicant
Xiamen Manteia Technology LTD.
1903, B Tower, Zijin Plaza, No.1811 Huandao East Road
Xiamen,  CN 361001
Applicant Contact Lu Xie
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 Received07/19/2019
Decision Date 02/28/2020
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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