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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K002519
Device Name VITREA 2, VERSION 2.1
Applicant
VITAL IMAGES, INC.
3300 FERNBROOK LN. NORTH
SUITE 200
PLYMOUTH,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
VITAL IMAGES, INC.
3300 FERNBROOK LN. NORTH
SUITE 200
PLYMOUTH,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/15/2000
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
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