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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K163213
Device Name Revolution CT
Applicant
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact Helen Peng
Correspondent
Ge Medical Systems, LLC
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact Helen Peng
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/16/2016
Decision Date 12/16/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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