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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, x-ray, tomography, computed
510(k) Number K003639
Device Name VITREA 2 CT PERFUSION OPTION
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 Number892.1750
Classification Product Code
JAK  
Date Received11/24/2000
Decision Date 01/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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