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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, imaging, pulsed echo, ultrasonic
510(k) Number K121689
Device Name VITASCAN LT SCANMASTER
Original Applicant
VITACON MEDICAL INC.
4020 viking way
unit 130
richmond,  CA v6v 2l4
Original Contact ron evans
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received06/07/2012
Decision Date 09/19/2012
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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