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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
Device Name VIVIX-S
Applicant
VIEWORKS CO., LTD.
951 STARBUCK ST
UNIT J
FULLERTON,  CA  92833
Applicant Contact Priscilla Chung
Correspondent
VIEWORKS CO., LTD.
951 STARBUCK ST
UNIT J
FULLERTON,  CA  92833
Correspondent Contact Priscilla Chung
Regulation Number892.1680
Classification Product Code
MQB  
Date Received01/03/2012
Decision Date 05/04/2012
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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