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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K180867
Device Name AmCAD-UO
Applicant
AmCad BioMed Corporation
FL. 5-2, No. 167, Fu Hsing N. RD.
Taipei,  TW 105
Applicant Contact Jack Yang
Correspondent
Lin & Associates, LLC
5614 Johnson Avenue
Bethesda,  MD  20817
Correspondent Contact Chiu S. Lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/02/2018
Decision Date 12/28/2018
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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