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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 K232710
Device Name Dental Cone-beam Computed Tomography
Applicant
Yian Medical Technology (Haining) Co., Ltd.
1st Floor Area 1, 2nd Floor Area 1, Building A,
No. 2 Caohejing Road, Haining Economic Development Zone
Jiaxing,  CN 314400
Applicant Contact Lili Yan
Correspondent
Yian Medical Technology (Haining) Co., Ltd
1st Floor Area 1, 2nd Floor Area 1, Building A,
No. 2 Caohejing Road, Haining Economic Development Zone
Jiaxing,  CN 314400
Correspondent Contact Lili Yan
Regulation Number892.1750
Classification Product Code
OAS  
Date Received09/05/2023
Decision Date 01/09/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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