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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 K012775
Device Name GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
Applicant
GE MEDICAL SYSTEMS
8380 DARROW RD.
TWINSBURG,  OH  44087
Applicant Contact GEOFFREY COCHRANE
Correspondent
GE MEDICAL SYSTEMS
8380 DARROW RD.
TWINSBURG,  OH  44087
Correspondent Contact GEOFFREY COCHRANE
Regulation Number892.1200
Classification Product Code
KPS  
Subsequent Product Code
JAK  
Date Received08/20/2001
Decision Date 09/18/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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