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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K092747
Device Name PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL
Applicant
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
595 MINER RD.
CLEVELAND,  OH  44143
Applicant Contact MICHAEL A CHILBERT
Correspondent
UNDERWRITERS LABORATORIES, INC.
1285 WALT WHITMAN RD.
MELVILLE,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/08/2009
Decision Date 10/09/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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