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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 K211725
Device Name Senographe Pristina
Applicant
GE Healthcare
283, Rue De La Miniere
Buc,  FR 78530
Applicant Contact Barthelemy Arman
Correspondent
GE Healthcare
283, Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Barthelemy Arman
Regulation Number892.1715
Classification Product Code
MUE  
Date Received06/04/2021
Decision Date 08/06/2021
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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