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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
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