FDA 510(k) Application Details - K992955

Device Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)   More FDA Info for this Device
510(K) Number	K992955
Device Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)
Applicant	IMAGING DYNAMICS CORP. 151,2340 PEGASUS WAY, NE CALGARY, ALBERTA T2E 8M5 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	09/01/1999
Decision Date	06/02/2000
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