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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 K131118
Device Name 4D VIEW
Applicant
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact BRYAN BEHN
Correspondent
GE Healthcare
9900 Innovation Dr.
Wauwatosa,  WI  53226
Correspondent Contact BRYAN BEHN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/2013
Decision Date 05/16/2013
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
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