VITREAVIEW


Device Classification Name

system, image processing, radiological

510(k) Number K122136
Device Name VITREAVIEW
Applicant
VITAL IMAGES, INC.
5850 opus pkwy ste 300
minnetonka, 
MN 
55343

Applicant Contact ian nemerov
Correspondent
VITAL IMAGES, INC.
5850 opus pkwy ste 300
minnetonka, 
MN 
55343

Correspodent Contact ian nemerov
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 07/18/2012
Decision Date 09/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No