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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 K051673
Device Name XELERIS 2 PROCESSING AND REVIEW WORKSTATION
Applicant
GE Medical Systems
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE Medical Systems
3000 N. Grandview Blvd.
W-709
Waukesha,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/23/2005
Decision Date 07/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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