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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 K113403
Model DISCOVERY IGS 730
Device Name GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM
Original Applicant
GE MEDICAL SYSTEMS SCS
283 rue de la miniere
buc,  FR 78530
Original Contact michel genuer
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
IZI   JAA  
Date Received11/17/2011
Decision Date 02/14/2012
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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