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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 K223621
Device Name DeepXray
Applicant
Alpha Intelligence Manifolds, Inc.
2f, # 170, Zhonghe Rd., Zhonghe District
New Taipei City,  TW 235068
Applicant Contact Qingzong Tseng
Correspondent
Alpha Intelligence Manifolds, Inc.
2f, # 170, Zhonghe Rd., Zhonghe District
New Taipei City,  TW 235068
Correspondent Contact Qingzong Tseng
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/05/2022
Decision Date 09/08/2023
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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