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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 K023768
Device Name ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16
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  
Date Received11/12/2002
Decision Date 11/25/2002
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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