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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 K050559
Device Name GE DISCOVERY VCT SYSTEM
Applicant
GE MEDICAL SYSTEMS
3000 NORTH GRANDVIEW BLVD.
W-400
WAUKESHA,  WI  53188
Applicant Contact D DUERSTELER
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received03/03/2005
Decision Date 03/17/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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