FDA 510(k) Application Details - K053610

Device Classification Name	System, X-Ray, Tomography, Computed   More FDA Info for this Device
510(K) Number	K053610
Device Name	System, X-Ray, Tomography, Computed
Applicant	TRAXTAL TECHNOLOGIES INC. 49 SPADINA AVENUE, #402C TORONTO, ONTARIO M5V 2J1 CA Other 510(k) Applications for this Company
Contact	NEIL GLOSSOP 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	12/27/2005
Decision Date	04/19/2006
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