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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 K052632
Device Name VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE
Applicant
VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA,  MN  55343 -4414
Applicant Contact TIMOTHY J KAPPERS
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/26/2005
Decision Date 12/15/2005
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
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