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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 K033431
Device Name LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ
Applicant
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Applicant Contact WILLIAM SKREMSKY
Correspondent
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932 -2571
Correspondent Contact WILLIAM SKREMSKY
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received10/28/2003
Decision Date 11/20/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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