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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K243045
Device Name “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
Applicant
Braxx Biotech Co., Ltd.
6f., #10, Songde Rd., Xinyi Dist
Taipei City,  TW 11076
Applicant Contact Wilson Lai
Correspondent
ZhengCheng Consulting Limited Company
6f., #148, Sec. 1, Jianguo N. Rd., Jhongshan Dist.
Taipei City,  TW 10489
Correspondent Contact Anita Chen
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received09/27/2024
Decision Date 11/19/2024
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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