FDA 510(k) Application Details - K242805

Device Classification Name	X-Ray, Tomography, Computed, Dental   More FDA Info for this Device
510(K) Number	K242805
Device Name	X-Ray, Tomography, Computed, Dental
Applicant	Changzhou Finno Medical Technology Co., Ltd. First Floor East and Third Floor, Building 5 No. 28 Yandanghe Road, Xinbei District Changzhou 213000 CN Other 510(k) Applications for this Company
Contact	Jie Zhu 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	09/17/2024
Decision Date	01/09/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review