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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 K122136
Device Name VITREAVIEW
Applicant
VITAL IMAGES, INC.
5850 Opus Pkwy Ste 300
MINNETONKA,  MN  55343
Applicant Contact Ian Nemerov
Correspondent
VITAL IMAGES, INC.
5850 Opus Pkwy Ste 300
MINNETONKA,  MN  55343
Correspondent Contact Ian Nemerov
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/18/2012
Decision Date 09/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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