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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 K260462
Device Name RCT800
Applicant
Ray Co., Ltd.
1f~3f, 4f(Part), 5f, 265, Daeji-Ro, Suji-Gu
Yongin-Si,  KR 16882
Applicant Contact Suyeon Baek
Correspondent
Ray Co., Ltd.
1f~3f, 4f(Part), 5f, 265, Daeji-Ro, Suji-Gu
Yongin-Si,  KR 16882
Correspondent Contact Suyeon Baek
Regulation Number892.1750
Classification Product Code
OAS  
Date Received02/12/2026
Decision Date 04/09/2026
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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