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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 K083658
Device Name PACS PLUS 5TH EDITION
Applicant
Medical Standard Co., Ltd.
49 Candlewood Way
Buena Park,  CA  90638
Applicant Contact BRANDON CHOI
Correspondent
Medical Standard Co., Ltd.
49 Candlewood Way
Buena Park,  CA  90638
Correspondent Contact BRANDON CHOI
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/10/2008
Decision Date 07/07/2009
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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