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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 K981027
Device Name E.CAM LSO 311 PET/SPECT SYSTEM
Applicant
Cti Pet Systems, Inc.
810 Innovation Dr.
P.O. Box 22999
Knoxville,  TN  37932 -2562
Applicant Contact WILLIAM SKREMSKY
Correspondent
Cti Pet Systems, Inc.
810 Innovation Dr.
P.O. Box 22999
Knoxville,  TN  37932 -2562
Correspondent Contact WILLIAM SKREMSKY
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/19/1998
Decision Date 06/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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