FDA 510(k) Application Details - K042408

Device Classification Name	Chest X-Ray Computer Aided Detection   More FDA Info for this Device
510(K) Number	K042408
Device Name	Chest X-Ray Computer Aided Detection
Applicant	EDDA TECHNOLOGY, INC. P.O. BOX 7007 DEERFIELD, IL 60015 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	OMJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/03/2004
Decision Date	10/08/2004
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