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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 K122429
Device Name VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Original Applicant
OBJECT RESEARCH SYSTEMS (ORS) INC.
760 st-paul west
suite 101
montreal,  CA h3c1m4
Original Contact eric f ournier
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/09/2012
Decision Date 11/28/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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