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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 K042467
Device Name LSO PET/CT HIREZ 64
Applicant
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Applicant Contact M. ALAINE MEDIO
Correspondent
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Correspondent Contact M. ALAINE MEDIO
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received09/13/2004
Decision Date 10/01/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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