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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 K122536
Device Name AMCAD-UT DETECTION MODEL 2.0
Applicant
LIN & ASSOCIATES, LLC.
9223 CAMBRIDGE MANOR COURT
POTOMAC,  MD  20854
Applicant Contact CHIU S LIN
Correspondent
LIN & ASSOCIATES, LLC.
9223 CAMBRIDGE MANOR COURT
POTOMAC,  MD  20854
Correspondent Contact CHIU S LIN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/20/2012
Decision Date 10/03/2013
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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