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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 K032748
Device Name VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
Applicant
VITAL IMAGES, INC.
3300 FERNBROOK LN. NORTH
SUITE 200
PLYMOUTH,  MN  55447
Applicant Contact STEPHEN S ANDERSON
Correspondent
VITAL IMAGES, INC.
3300 FERNBROOK LN. NORTH
SUITE 200
PLYMOUTH,  MN  55447
Correspondent Contact STEPHEN S ANDERSON
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/05/2003
Decision Date 10/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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