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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 K251351
Device Name AccuContour 4.0
Applicant
Manteia Technologies Co., Ltd.
Unit 3001-3005, #5 Huizhan N. Rd.
Xiamen,  CN 361008
Applicant Contact Chao Fang
Correspondent
Manteia Technologies Co., Ltd.
Unit 3001-3005, #5 Huizhan N. Rd.
Xiamen,  CN 361008
Correspondent Contact Chao Fang
Regulation Number892.2050
Classification Product Code
QKB  
Date Received04/30/2025
Decision Date 01/23/2026
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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