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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Full Field Digital, System, X-Ray, Mammographic
510(k) Number K110798
Device Name SENOGRAPHE DS, SENOGRAPHE ESSENTIAL
Applicant
General Electric Company
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Applicant Contact STEVEN KACHELMEYER
Correspondent
General Electric Company
3000 N. Grandview Blvd.
Waukesha,  WI  53188
Correspondent Contact STEVEN KACHELMEYER
Regulation Number892.1715
Classification Product Code
MUE  
Date Received03/22/2011
Decision Date 12/22/2011
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
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