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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 K172404
Device Name SenoBright HD
Applicant
Ge Healthcare
283 Rue De La Miniere
Buc,  FR 78530
Applicant Contact Mounir Zaouali
Correspondent
Ge Healthcare
283 Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Mounir Zaouali
Regulation Number892.1715
Classification Product Code
MUE  
Date Received08/09/2017
Decision Date 10/30/2017
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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