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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
AmCad BioMed Corporation
FL.3, NO. 167, Fu Hsing N. RD.
Taipei,  TW 105
Applicant Contact Jack Yang
Lin & Associates, LLC
9223 Cambridge Manor Court
Potomac,  MD  20854
Correspondent Contact Chiu S. Lin
Regulation Number892.2050
Classification Product Code
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