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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, fluoroscopic, image-intensified
510(k) Number K862120
Device Name SCX SYSTEM
Original Applicant
GENERAL ELECTRIC CO.
p.o. box 414
milwaukee,  WI  53201
Original Contact howard, ii
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/03/1986
Decision Date 06/16/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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