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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 K103182
Device Name TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
Applicant
Genoray Co., Ltd.
1073 N. Batavia St.
Orange,  CA  92867
Applicant Contact JAE KIM
Correspondent
Genoray Co., Ltd.
1073 N. Batavia St.
Orange,  CA  92867
Correspondent Contact JAE KIM
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/28/2010
Decision Date 01/14/2011
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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