FDA 510(k) Application Details - K243556

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K243556
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	iRay Imaging Technology (Haining) Limited No. 2, Caohejing Rd. Jiaxing Haining 314499 CN Other 510(k) Applications for this Company
Contact	Junjie Qian Other 510(k) Applications for this Contact
Regulation Number	892.1650   More FDA Info for this Regulation Number
Classification Product Code	MQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2024
Decision Date	03/18/2025
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