FDA 510(k) Application Details - K193173

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K193173
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	CareRay Digital Medical System Co., Ltd. A2-201/B3-501, Biobay, 218 Xinghu Street, SuZhou Industrial Park Suzhou 215123 CN Other 510(k) Applications for this Company
Contact	Leilei 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	11/18/2019
Decision Date	12/13/2019
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