FDA 510(k) Application Details - K123345

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K123345
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	RAYENCE CO., LTD 12946 KIMBERLEY LN HOUSTON, TX 77079 US Other 510(k) Applications for this Company
Contact	DAVE KIM 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	10/31/2012
Decision Date	03/12/2013
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