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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 K182951
Device Name Pristina Serena 3D
Applicant
GE Healthcare
28 rue de la Miniere
Buc,  FR 78530
Applicant Contact Nicole Landreville
Correspondent
GE Healthcare
283 rue de la Miniere
Buc,  FR 78530
Correspondent Contact Nicole Landreville
Regulation Number892.1715
Classification Product Code
MUE  
Date Received10/23/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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