FDA 510(k) Application Details - K071403

Device Classification Name	System, X-Ray, Stationary   More FDA Info for this Device
510(K) Number	K071403
Device Name	System, X-Ray, Stationary
Applicant	IMAGING DYNAMICS COMPANY LTD. 2340 PEGASUS WAY, NE SUITE 151 CALGARY T2E 8M5 CA Other 510(k) Applications for this Company
Contact	SHIRANTHAN 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	05/21/2007
Decision Date	06/11/2007
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