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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 K081496
Device Name OPTIMA PET/CT 560
Applicant
GE MEDICAL SYSTEMS, LLC
3000 n grandview blvd.
waukesha,  WI  53188
Applicant Contact david duersteler
Correspondent
INTERTEK TESTING SERVICES
2307 east aurora road
unit b7
twinsburg,  OH  44087
Correspondent Contact jay y kogoma
Regulation Number892.1200
Classification Product Code
KPS  
Date Received05/29/2008
Decision Date 06/12/2008
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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