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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 K152584
Device Name Stroke VCAR
Applicant
GE Medical Systems SCS
283, Rue De La Miniere
Buc,  FR 78530
Applicant Contact Peter Uhlir
Correspondent
GE Healthcare
540 W Northwest Hwy.
Barrington,  IL  60010
Correspondent Contact Jeme Wallace
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/10/2015
Decision Date 01/20/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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