VITREA CT MYOCARDIAL ANALYSIS


Device Classification Name

system, image processing, radiological

510(k) Number K112531
Device Name VITREA CT MYOCARDIAL ANALYSIS
Applicant
VITAL IMAGES, INC.
5850 opus parkway,
suite 300
minnetonka, 
MN 
55343 -4414

Applicant Contact daniel biank
Correspondent
VITAL IMAGES, INC.
5850 opus parkway,
suite 300
minnetonka, 
MN 
55343 -4414

Correspodent Contact daniel biank
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/31/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No