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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 K163302
Device Name Senographe Pristina
GE Healthcare
283 rue de la Miniere
Buc,  FR 78530
Applicant Contact Camille Vidal
GE Healthcare
283 rue de la Miniere
Buc,  FR 78530
Correspondent Contact Camille Vidal
Regulation Number892.1715
Classification Product Code
Date Received11/22/2016
Decision Date 09/01/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No