FDA 510(k) Application Details - K053046

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K053046
Device Name	System, X-Ray, Tomography, Computed
Applicant	IMTEC CORP. 2401 NORTH COMMERCE ARDMORE, OK 73401 US Other 510(k) Applications for this Company
Contact	J. BRAD VANCE Other 510(k) Applications for this Contact
Regulation Number	892.1750   More FDA Info for this Regulation Number
Classification Product Code	JAK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/28/2005
Decision Date	11/08/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review