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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 K130884
Device Name XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION
Original Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 hayozma st.
tirat hacarmel,  IL 30200
Original Contact eli werner
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received03/29/2013
Decision Date 04/12/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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