FDA 510(k) Application Details - K061361

Device Classification Name	Cabinet,X-Ray System   More FDA Info for this Device
510(K) Number	K061361
Device Name	Cabinet,X-Ray System
Applicant	FAXITRON X-RAY CORP. 225 LARKIN DR.,SUITE 1 WHEELING, IL 60090 US Other 510(k) Applications for this Company
Contact	DOUGLAS C WIEGMAN Other 510(k) Applications for this Contact
Regulation Number	892.1680   More FDA Info for this Regulation Number
Classification Product Code	MWP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2006
Decision Date	08/15/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review