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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 K220264
Device Name EFAI RTSuite CT HN-Segmentation System
Applicant
Ever Fortune.AI Co., Ltd.
Rm. D, 8F. No. 573, Sec. 2 Taiwan Blvd., West Dist.
Taichung City,  TW 403020
Applicant Contact Joseph Chang
Correspondent
Ever Fortune.AI Co., Ltd.
Rm. D, 8F. 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 Received01/31/2022
Decision Date 04/28/2022
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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