FDA 510(k) Application Details - K050843

Device Classification Name	System, Therapeutic, X-Ray   More FDA Info for this Device
510(K) Number	K050843
Device Name	System, Therapeutic, X-Ray
Applicant	XOFT, INC. 49000 MILMONT DRIVE FREMONT, CA 94538 US Other 510(k) Applications for this Company
Contact	Kathy O'Shaughnessy Other 510(k) Applications for this Contact
Regulation Number	892.5900   More FDA Info for this Regulation Number
Classification Product Code	JAD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/01/2005
Decision Date	12/22/2005
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review