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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
Contact andrew paeng
Regulation Number872.1800
Classification Product Code
MUH  
Date Received09/24/2012
Decision Date 03/15/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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