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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K223490
Device Name FlightPlan for Embolization
Applicant
GE Medical Systems SCS
283, rue de la Miniere
Buc,  FR 78530
Applicant Contact Ning Wen
Correspondent
GE Medical Systems SCS
283, rue de la Miniere
Buc,  FR 78530
Correspondent Contact Ning Wen
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/21/2022
Decision Date 03/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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