FDA 510(k) Application Details - K042041

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K042041
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	IMAGING DYNAMICS COMPANY LIMITED 151,2340 PEGASUS WAY NE CALGARY T3G3X5 CA Other 510(k) Applications for this Company
Contact	ROBIN WINSOR 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	07/29/2004
Decision Date	09/17/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review