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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, Tomography, Computed
510(k) Number K193289
Device Name FastStroke, CT Perfusion 4D
Applicant
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Applicant Contact Elizabeth Mathew
Correspondent
GE Medical Systems SCS
283 rue de la Miniere
Buc,  FR 78530
Correspondent Contact Elizabeth Mathew
Regulation Number892.1750
Classification Product Code
JAK  
Subsequent Product Code
LLZ  
Date Received11/27/2019
Decision Date 11/12/2020
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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