VITREA 4DCT


Device Classification Name

system, image processing, radiological

510(k) Number K072821
Device Name VITREA 4DCT
Applicant
VITAL IMAGES, INC.
5850 opus parkway,
suite 300
minnetonka, 
MN 
55343 -4414

Applicant Contact timothy j kappers
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 10/02/2007
Decision Date 02/20/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls