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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 K260087
Device Name Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright
Applicant
GE Medical Systems SCS
283, Rue De La Miniere
Buc,  FR 78530
Applicant Contact Fayçal Kherra
Correspondent
GE Medical Systems SCS
283, Rue De La Miniere
Buc,  FR 78530
Correspondent Contact Fayçal Kherra
Regulation Number892.1715
Classification Product Code
MUE  
Date Received01/12/2026
Decision Date 03/24/2026
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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