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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 K201103
Device Name Xeleris V Processing and Review Systems
Applicant
Ge Healthcare
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Applicant Contact Alexandra Lifshits
Correspondent
Ge Healthcare
4 Hayozma St.
Tirat Hacarmel,  IL 30200
Correspondent Contact Alexandra Lifshits
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/24/2020
Decision Date 09/25/2020
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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