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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 K042257
Device Name DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION
Applicant
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Applicant Contact DAVID DUERSTELER
Correspondent
GENERAL ELECTRIC CO.
P.O. BOX 414
MILWAUKEE,  WI  53201
Correspondent Contact DAVID DUERSTELER
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received08/20/2004
Decision Date 09/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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