FDA 510(k) Application Details - K061595

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K061595
Device Name	System, X-Ray, Stationary
Applicant	IMAGING DYNAMICS COMPANY LTD. 151,2340 PEGASUS WAY, NE CALGARY, ALBERTA T2E 8M5 CA Other 510(k) Applications for this Company
Contact	SHIRANTHA SAMARAPPULI Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	KPR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/08/2006
Decision Date	08/17/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review