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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Extraoral Source, Digital
510(k) Number K142058
Device Name RAYSCAN A-EXPERT
Applicant
Ray Co., Ltd.
4747 Hoen Ave.
Santa Rosa,  CA  95405
Applicant Contact ANDEW PAENG
Correspondent
Ray Co., Ltd.
4747 Hoen Ave.
Santa Rosa,  CA  95405
Correspondent Contact ANDEW PAENG
Regulation Number872.1800
Classification Product Code
MUH  
Date Received07/29/2014
Decision Date 04/22/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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