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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 K133278
Device Name DISCOVERY IGS 740
Applicant
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
BUC,  FR 78530
Applicant Contact MICHEL GENUER
Correspondent
GE MEDICAL SYSTEMS SCS
283 RUE DE LA MINIERE
BUC,  FR 78530
Correspondent Contact MICHEL GENUER
Regulation Number892.1650
Classification Product Code
OWB  
Subsequent Product Codes
JAA   OXO  
Date Received10/24/2013
Decision Date 04/24/2014
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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