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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
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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