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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 K123596
Device Name OPTIMA CT520
Original Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
no. 2 n. yongchang street
beijing economic & technological development area
beijing,  CH 100176
Original Contact helen peng
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/21/2012
Decision Date 02/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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