VITREA 2, VERSION 2.1


information about

Device Classification Name

system, image processing, radiological

510(k) Number K002519
Device Name VITREA 2, VERSION 2.1
Original Applicant
VITAL IMAGES, INC.
3300 fernbrook ln. north
suite 200
plymouth, 
MN 
55447

Original Contact robert c samec
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 08/15/2000
Decision Date 10/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls