FDA 510(k) Application Details - K041605

Device Classification Name	More FDA Info for this Device
510(K) Number	K041605
Device Name	PRECISION RXI ANALOG X-RAY SYSTEM
Applicant	GENERAL MEDICAL MERATE S.P.A. 25 VIA PARTIGIANI SERIATE (BG) 24068 IT Other 510(k) Applications for this Company
Contact	Kevin Walls Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/15/2004
Decision Date	06/30/2004
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	Y
Expedited Review