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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
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