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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
Applicant
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO. 2 N. YONGCHANG STREET
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA
BEIJING,  CN 100176
Applicant Contact HELEN PENG
Correspondent
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
NO. 2 N. YONGCHANG STREET
BEIJING ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA
BEIJING,  CN 100176
Correspondent Contact HELEN PENG
Regulation Number892.1750
Classification Product Code
JAK  
Date Received11/21/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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