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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 K231928
Device Name EFAI RTSUITE CT HCAP-Segmentation System
Applicant
Ever Fortune.AI Co., Ltd.
8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.AI Co., Ltd.
8 F., No. 573, Sec. 2, Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Correspondent Contact Ti-Hao Wang
Regulation Number892.2050
Classification Product Code
QKB  
Date Received06/30/2023
Decision Date 09/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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