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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
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
540 ALDER DRIVE
MILPITAS,  CA  95035
Applicant Contact COLEEN A COLEMAN
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN CHRISTENSEN
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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