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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 K203555
Device Name AmCAD-UT
Applicant
AmCad BioMed Corporation
FL. 5-2, No.167, Fu Hsing N. RD.
Taipei,  TW 105
Applicant Contact Nathan Liu
Correspondent
AmCad BioMed Corporation
FL.5-2, NO.167, Fu Hsing N. RD.
Taipei 105,  TW
Correspondent Contact Nathan Liu
Regulation Number892.2050
Classification Product Code
QIH  
Date Received12/07/2020
Decision Date 09/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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