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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
Predetermined Change
Control Plan Authorized		 No
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