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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 K122918
Device Name RAYSCAN A-EXPERT
Applicant
Ray Co., Ltd.
8920 Wilshire Bllvd
Suite 603
Beverly Hills,  CA  90211
Applicant Contact ANDREW PAENG
Correspondent
Ray Co., Ltd.
8920 Wilshire Bllvd
Suite 603
Beverly Hills,  CA  90211
Correspondent Contact ANDREW PAENG
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/24/2012
Decision Date 03/15/2013
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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