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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 K221680
Device Name Xeleris V Processing and Review System
Applicant
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Applicant Contact George Mashour
Correspondent
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Correspondent Contact George Mashour
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/09/2022
Decision Date 03/01/2023
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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