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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 K090553
Device Name NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER
Applicant
Naviscan, Inc.
6865 Flanders Dr.
Suite B
San Diego,  CA  92121
Applicant Contact HEATHER JALISI
Correspondent
Naviscan, Inc.
6865 Flanders Dr.
Suite B
San Diego,  CA  92121
Correspondent Contact HEATHER JALISI
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/02/2009
Decision Date 03/31/2009
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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