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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 K132302
Device Name QXLINK
Applicant
Vieworks Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
Vieworks Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/24/2013
Decision Date 09/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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