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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 K252190
Device Name DeepBT Detector-Plus
Applicant
Aitewan Biomedical Technology, Inc.
7f., # 1, Yumin 6th Rd., Beitou Dist.
Taipei,  TW
Applicant Contact Wan-Yuo Guo
Correspondent
Aitewan Biomedical Technology, Inc.
7f., # 1, Yumin 6th Rd., Beitou Dist.
Taipei,  TW
Correspondent Contact Ya-Xuan Yang
Regulation Number892.2050
Classification Product Code
QKB  
Date Received07/14/2025
Decision Date 04/10/2026
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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