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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 K142247
Device Name RAYSCAN A-EXPERT 3D
Applicant
RAY CO., LTD
332-7, SAMSUNG1-RO
HWASEONG-SI,  KR 445-330
Applicant Contact KYUNGHA SEO
Correspondent
ANDEW PAENG
4747 HOEN AVE.
SANTA ROSA,  CA  95405
Correspondent Contact ANDEW PAENG
Regulation Number892.1750
Classification Product Code
OAS  
Date Received07/29/2014
Decision Date 04/17/2015
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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