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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, angiographic
510(k) Number K122457
Models INNOVA 2121-IQ, INNOVA 3131-IQ, INNOVA 4100-IQ, INNOVA3100-IQ, INNOVA 2100-IQ, INNOVA IGS 540, INNOVA IGS 530, INNOVA IGS 520, INNOVA IGS 620, INNOVS IGS 630, DISCOVERY IGS 730, OPTIMA CL320I, OPTIMA CL323I
Device Name GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS
Original Applicant
GE HEALTHCARE
283, rue de la miniere
buc,  FR 78530
Original Contact malca
Regulation Number892.1600
Classification Product Code
IZI  
Date Received08/13/2012
Decision Date 01/02/2013
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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