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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 K962797
Device Name ECAT EXACT & ECAT EXACT HR+
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 Received07/18/1996
Decision Date 10/15/1996
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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