FDA 510(k) Application Details - K201591

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K201591
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	KA Imaging Inc. 560 Parkside Dr #3 Waterloo N2L 5Z4 CA Other 510(k) Applications for this Company
Contact	Samuel To 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	06/12/2020
Decision Date	09/03/2020
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