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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 K920624
Device Name ECAT EXACT HR MODEL 961
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 Received02/11/1992
Decision Date 04/27/1992
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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