FDA 510(k) Application Details - K052938

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K052938
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	ERADLINK, INC. 22750 HAWTHORNE BLVD. TORRANCE, CA 90505-3664 US Other 510(k) Applications for this Company
Contact	ALBERT KOUBA 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	10/20/2005
Decision Date	11/17/2005
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