FDA 510(k) Application Details - K183713

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K183713
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	iRay Technology Taicang Ltd. No. 33 Xinggang Rd., Taicang Port Economic & Technological Development Zone Taicang 215434 CN Other 510(k) Applications for this Company
Contact	Meng Li 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	12/10/2018
Decision Date	01/09/2019
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