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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
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Applicant Contact Alexandra Lifshits
GE Healthcare
4 Hayozma Street
Tirat Hacarmel,  IL 30200
Correspondent Contact Alexandra Lifshits
Regulation Number892.2050
Classification Product Code
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