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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 K080927
Device Name BRIGHTVIEW VCT IMAGING SYSTEM
Original Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
540 alder drive
milpitas,  CA  95035
Original Contact coleen a coleman
Regulation Number892.1200
Classification Product Code
KPS  
Date Received04/02/2008
Decision Date 04/11/2008
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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