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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 K251842
Device Name Dental Computed Tomography X-ray System
Applicant
Fussen Technology Co., Ltd.
901,1001, Bldg. #D1, Nanshan Zhiyuan, 1001 Xueyuan
Ave., Changyuan Community, Taoyuan St., Nanshan Dist.
Shenzhen,  CN 518055
Applicant Contact Guiqin Zheng
Correspondent
Landlink Healthcare Technology (Shanghai) Co., Ltd.
Rm. 1308, Baohua International Plaza, W. Guangzhong
Rd. 555, Jingan District
Shanghai,  CN
Correspondent Contact Kyra Kang
Regulation Number892.1750
Classification Product Code
OAS  
Date Received06/16/2025
Decision Date 11/13/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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