FDA 510(k) Application Details - K150929

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K150929
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 QUALITY DEPARTMENT SUNZHOU 215123 CN Other 510(k) Applications for this Company
Contact	YULING DING 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	04/06/2015
Decision Date	08/04/2015
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