FDA 510(k) Application Details - K003568

Device Classification Name	More FDA Info for this Device
510(K) Number	K003568
Device Name	XISCAN 6000 IMAGING SYSTEM
Applicant	XITEC, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760 US Other 510(k) Applications for this Company
Contact	SHEILA M HEMEON-HEYER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2000
Decision Date	12/27/2000
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