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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, stationary
510(k) Number K870400
Device Name SCX INFORMATION MANAGEMENT SYSTEM
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact LARRY KROGER
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact LARRY KROGER
Regulation Number892.1680
Classification Product Code
KPR  
Date Received02/02/1987
Decision Date 06/18/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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