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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 K073056
Device Name DIGITAL RADIOGRAPHY SYSTEM, MODEL: QXR-9
Applicant
VIEWORKS CO., LTD.
307-2, SANGDAEWON-DONG
JUNGWON-GU, SEONGNAM-CITY,
GYEONGGI-DO,  KR 462-806
Applicant Contact KIM RAZA
Correspondent
UNDERWRITERS LABORATORIES, INC.
455 E. TRIMBLE ROAD
SAN JOSE,  CA  95131 -1230
Correspondent Contact MORTEN S CHRISTENSEN
Regulation Number892.1680
Classification Product Code
MQB  
Date Received10/30/2007
Decision Date 11/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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