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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K042692
Device Name CLARITY FUSION
Applicant
Shared P.E.T. Imaging, LLC
710 A St., NE
Washington,  DC  20002
Applicant Contact RUSS PAGANO
Correspondent
Shared P.E.T. Imaging, LLC
710 A St., NE
Washington,  DC  20002
Correspondent Contact RUSS PAGANO
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/30/2004
Decision Date 10/07/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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