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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name solid state x-ray imager (flat panel/digital imager)
510(k) Number K120020
Models FXRD-1417B, FXRD-1417SA, FXRD-1717SA, FXRD-1717SB
Device Name VIVIX-S
Original Applicant
951 starbuck st
unit j
fullerton,  CA  92833
Original Contact priscilla chung
Regulation Number892.1680
Classification Product Code
Date Received01/03/2012
Decision Date 05/04/2012
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