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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K234042
Device Name EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
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
QIH  
Date Received12/21/2023
Decision Date 06/07/2024
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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