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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, tomography, computed, emission
510(k) Number K141074
Device Name CORTEX ID SUITE
Applicant
GE MEDICAL SYSTEMS, LLC
3000 N GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact DAVID DUERSTELER
Correspondent
GE MEDICAL SYSTEMS, LLC
540 W. NORTHWEST HWY.
BARRINGTON,  IL  60010
Correspondent Contact JEME WALLACE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/25/2014
Decision Date 09/18/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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