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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 K913637
Device Name ECAT SCANNER (MODEL 921)
Applicant
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
P.O. BOX 22999
KNOXVILLE,  TN  37932 -2562
Applicant Contact DONALD A PERRINE
Correspondent
CTI PET SYSTEMS, INC.
810 INNOVATION DR.
P.O. BOX 22999
KNOXVILLE,  TN  37932 -2562
Correspondent Contact DONALD A PERRINE
Regulation Number892.1200
Classification Product Code
KPS  
Date Received08/15/1991
Decision Date 11/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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