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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
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