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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
Applicant Contact M. ALAINE MEDIO
Correspondent
Cti Pet Systems, Inc.
810 Innovation Dr.
Knoxville,  TN  37932
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
Predetermined Change
Control Plan Authorized		 No
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