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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
Predetermined Change
Control Plan Authorized		 No
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