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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 K093982
Device Name XELERIS 3 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.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/24/2009
Decision Date 01/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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