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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
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