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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K092081
Device Name QXLINK
Applicant
Vieworks Co., Ltd.
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607 -9526
Correspondent Contact MARC MOUSER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/09/2009
Decision Date 07/21/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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