FDA 510(k) Application Details - K013631

Device Classification Name	Digitizer, Image, Radiological   More FDA Info for this Device
510(K) Number	K013631
Device Name	Digitizer, Image, Radiological
Applicant	EFILM MEDICAL, INC. 500 UNIVERSITY AVE., SUITE 300 TORONTO, ONTARIO M5G 1V7 CA Other 510(k) Applications for this Company
Contact	JOSEPH A THOMAS Other 510(k) Applications for this Contact
Regulation Number	892.2030   More FDA Info for this Regulation Number
Classification Product Code	LMA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2001
Decision Date	11/20/2001
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	Y
Expedited Review