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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 K181403
Device Name Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
GE Healthcare
283 Rue de la Miniere
Buc,  FR 78530
Applicant Contact Michel Genuer
GE Healthcare
283 Rue de la Miniere
Buc,  FR 78530
Correspondent Contact Michel Genuer
Regulation Number892.1650
Classification Product Code
Subsequent Product Codes
Date Received05/29/2018
Decision Date 11/02/2018
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