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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 K170069
Device Name AmCAD-UV
Applicant
AmCad BioMed Corporation
FL.3, NO. 167, Fu Hsing N. RD.
Taipei,  TW 105
Applicant Contact Jack Yang
Correspondent
Lin & Associates, LLC
9223 Cambridge Manor Court
Potomac,  MD  20854
Correspondent Contact Chiu S. Lin
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received01/09/2017
Decision Date 04/26/2017
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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