FDA 510(k) Application Details - K242499

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K242499
Device Name	System, X-Ray, Stationary
Applicant	ShenzhenáSONTUáMedicaláImagingáEquipmentáCo., Ltd. 101, 202, Bldg 1, Shenzhen Biomedicine Innovations Indust Pk No. 14 Jinhui Rd, Jinsha Community, Kengzi St, Pingshan Dist Shenzhen 518122 CN Other 510(k) Applications for this Company
Contact	Xiaomei Lao Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2024
Decision Date	01/06/2025
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