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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name X-Ray, Tomography, Computed, Dental
510(k) Number K122981
Device Name RAYSCAN A-EXPERT 3D
Applicant
Ray Co., Ltd.
8920 Wilshire Blvd.
Suite 603
Beverly Hills,  CA  90211
Applicant Contact ANDREW PAENG
Correspondent
Ray Co., Ltd.
8920 Wilshire Blvd.
Suite 603
Beverly Hills,  CA  90211
Correspondent Contact ANDREW PAENG
Regulation Number892.1750
Classification Product Code
OAS  
Date Received09/24/2012
Decision Date 03/12/2013
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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