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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K120613
Device Name OEC 9900 ELITE
Applicant
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY,  UT  84116
Applicant Contact GERALD BUSS
Correspondent
GE HEALTHCARE SURGERY GE OEC MEDICAL SYSTEMS, INC
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY,  UT  84116
Correspondent Contact GERALD BUSS
Regulation Number892.1650
Classification Product Code
OXO  
Subsequent Product Codes
JAA   OWB  
Date Received02/29/2012
Decision Date 04/06/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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