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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
510(k) Number K253192
Device Name DeepXray Spina
Applicant
Alpha Intelligence Manifolds, Inc.
2f, # 170, Zhonghe Rd., Zhonghe Dist.
New Taipei City,  TW 235068
Applicant Contact Qingzong TSENG
Correspondent
Alpha Intelligence Manifolds, Inc.
2f, # 170, Zhonghe Rd., Zhonghe Dist.
New Taipei City,  TW 235068
Correspondent Contact Qingzong TSENG
Classification Product Code
SAO  
Subsequent Product Code
KGI  
Date Received09/26/2025
Decision Date 06/10/2026
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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