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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 K024137
Device Name JUPITER PROCESSING AND REVIEW WORKSTATION
Applicant
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
waukesha,  WI  53188
Applicant Contact larry a kroger
Correspondent
GE MEDICAL SYSTEMS, INC.
3000 N. GRANDVIEW BLVD.
waukesha,  WI  53188
Correspondent Contact larry a kroger
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/16/2002
Decision Date 01/15/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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