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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K172027
Device Name Adani MammoScan
Applicant
ADANI
Selitski St., 7
Minsk,  BY 220075
Applicant Contact Vladimir Klokov
Correspondent
Kamm & Associates
8870 Ravello Ct.
Naples,  FL  34114
Correspondent Contact Daniel Kamm
Regulation Number892.1715
Classification Product Code
MUE  
Date Received07/05/2017
Decision Date 10/20/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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