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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 K052855
Device Name STARSPEED SERIES CT SCANNER SYSTEMS
Applicant
GE HEALTHCARE
3000 N. GRANDVIEW BLVD
WAUKESHA,  WI  53188
Applicant Contact LEKSHMI NAIR
Correspondent
TUV RHEINLAND OF NORTH AMERICA, INC.
12 COMMERCE RD.
NEWTON,  CT  06470
Correspondent Contact TAMAS BORSAI
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/11/2005
Decision Date 10/28/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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