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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 K232287
Device Name RAYSCAN a-Expert3D
Applicant
Ray Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Applicant Contact Sooji Huh
Correspondent
Ray Co., Ltd.
1F~3F, 4F(Part), 5F, 265, Daeji-Ro, Suji-gu
Yongin-si,  KR 16882
Correspondent Contact Sooji Huh
Regulation Number892.1750
Classification Product Code
OAS  
Date Received08/01/2023
Decision Date 08/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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