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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
Applicant Contact WILLIAM SKREMSKY
Correspondent
Cti Pet Systems, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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