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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 K211215
Device Name SenoBright HD
GE Healthcare
283 Rue de la Minière
Buc,  FR 78530
Applicant Contact Florian Akpakpa
GE Healthcare
283 Rue de la Minière
Buc,  FR 78530
Correspondent Contact Florian Akpakpa
Regulation Number892.1715
Classification Product Code
Date Received04/23/2021
Decision Date 06/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls