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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 K251306
Device Name Seg Pro V3 (RT-300)
Applicant
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.Ai, Co., Ltd.
8f. # 360, Sec.1 Jingmao Rd., Beitun Dist.
Taichung City,  TW 406040
Correspondent Contact Ti-Hao Wang
Regulation Number892.2050
Classification Product Code
QKB  
Date Received04/28/2025
Decision Date 01/28/2026
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		 Yes
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