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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, Mammographic
510(k) Number K881882
Device Name SENOGRAPHE 600T AND 600TS SENIX HF
Applicant
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Applicant Contact KROGER, PHD
Correspondent
General Electric Co.
P.O. Box 414
Milwaukee,  WI  53201
Correspondent Contact KROGER, PHD
Regulation Number892.1710
Classification Product Code
IZH  
Date Received05/04/1988
Decision Date 05/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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