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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 K121213
FOIA Releasable 510(k) K121213
Device Name VITREAADVANCED
Applicant
VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA,  MN  55343 -4414
Applicant Contact Daniel Biank
Correspondent
VITAL IMAGES, INC.
5850 OPUS PARKWAY,
SUITE 300
MINNETONKA,  MN  55343 -4414
Correspondent Contact Daniel Biank
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/20/2012
Decision Date 11/02/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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