FDA 510(k) Application Details - K081963

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K081963
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	AGFA HEALTHCARE CORPORATION 10 SOUTH ACADEMY STREET GREENVILLE, SC 29601 US Other 510(k) Applications for this Company
Contact	JEFFERY A JEDLICKA 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	07/10/2008
Decision Date	07/25/2008
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	Y
Expedited Review