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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Interventional Fluoroscopic X-Ray System
510(k) Number K122457
Device Name GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
Applicant
GE HEALTHCARE
283, RUE DE LA MINIERE
BUC,  FR 78530
Applicant Contact MALCA
Correspondent
GE HEALTHCARE
283, RUE DE LA MINIERE
BUC,  FR 78530
Correspondent Contact MALCA
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received08/13/2012
Decision Date 01/02/2013
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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