FDA 510(k) Application Details - K251642

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K251642
Device Name	X-Ray, Tomography, Computed, Dental
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, Haichang Haining, Jiaxing 314400 CN Other 510(k) Applications for this Company
Contact	Lili Yan Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	OAS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/29/2025
Decision Date	06/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review