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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
Applicant
GE MEDICAL SYSTEMS F.I. HAIFA
4 HAYOZMA ST.
TIRAT HACARMEL,  IL 30200
Applicant Contact ELI WERNER
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact NED DEVINE
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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