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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 K003230
Device Name V SCORE WITH AUTO GATE MODEL TBD
Applicant
Vital Images, Inc.
3300 Fernbrook Ln. N.
Suite 200
Plymouth,  MN  55447
Applicant Contact ROBERT C SAMEC
Correspondent
Vital Images, Inc.
3300 Fernbrook Ln. N.
Suite 200
Plymouth,  MN  55447
Correspondent Contact ROBERT C SAMEC
Regulation Number892.1750
Classification Product Code
JAK  
Date Received10/16/2000
Decision Date 12/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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