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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 K910048
Device Name ECAT SCANNER
Applicant
Cti Pet Systems, Inc.
810 Innovation Dr.
P.O. Box 22999
Knoxville,  TN  37932
Applicant Contact MARK S ANDREACO
Correspondent
Cti Pet Systems, Inc.
810 Innovation Dr.
P.O. Box 22999
Knoxville,  TN  37932
Correspondent Contact MARK S ANDREACO
Regulation Number892.1200
Classification Product Code
KPS  
Date Received01/07/1991
Decision Date 05/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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