FDA 510(k) Application Details - K984406

Device Classification Name	More FDA Info for this Device
510(K) Number	K984406
Device Name	XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
Applicant	XITEC, INC. 49 PLAIN ST. NORTH ATTLEBORO, MA 02760-4153 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	12/09/1998
Decision Date	02/02/1999
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