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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 K122866
Device Name VIVIX-S WITH VXVUE
Applicant
Vieworks Co., Ltd.
951 St.arbuck St.
Unit J
Fullerton,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
Vieworks Co., Ltd.
951 St.arbuck St.
Unit J
Fullerton,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
MQB  
Date Received09/18/2012
Decision Date 01/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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