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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 K263033
Device Name Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800)
Applicant
Fussen Technology Co., Ltd.
901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan Ave., Cha
Shenzhen,  CN 518055
Applicant Contact Guiqin Zheng
Correspondent
Fussen Technology Co., Ltd.
901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan Ave., Cha
Shenzhen,  CN 518055
Correspondent Contact Guiqin Zheng
Regulation Number892.1750
Classification Product Code
OAS  
Date Received08/31/2026
Decision Date 09/30/2026
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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