VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL


Device Classification Name

system, image processing, radiological

510(k) Number K122429
Device Name VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Applicant
OBJECT RESEARCH SYSTEMS (ORS) INC.
760 st-paul west
suite 101
montreal, 

CA

h3c1m4

Applicant Contact eric f ournier
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/09/2012
Decision Date 11/28/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No