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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K233714
Device Name BreView
Applicant
GE Medical Systems SCS
283 Rue De La Miniere
78530 Buc
Buc,  FR 78530
Applicant Contact Indu Karun
Correspondent
GE Medical Systems SCS
283 Rue De La Miniere
78530 Buc
Buc,  FR 78530
Correspondent Contact Indu Karun
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/20/2023
Decision Date 01/25/2024
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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