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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 K113456
Device Name READY VIEW
Applicant
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
3144 N GRANDVIEW BLVD,
MAIL STOP- W-501
WAUKESHA,  WI  53188
Applicant Contact ELIZABETH MATHEW
Correspondent
GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
3144 N GRANDVIEW BLVD,
MAIL STOP- W-501
WAUKESHA,  WI  53188
Correspondent Contact ELIZABETH MATHEW
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/21/2011
Decision Date 06/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
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