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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 K001682
Device Name VSCORE WITH EKG SIGNAL GATING
Original Applicant
VITAL IMAGES, INC.
3300 fernbrook ln. north
suite 200
plymouth,  MN  55447
Original Contact robert c samec
Regulation Number892.1750
Classification Product Code
JAK  
Date Received06/01/2000
Decision Date 06/30/2000
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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