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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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