FDA 510(k) Application Details - K042733

Device Classification Name	Instrument, Quality-Assurance, Radiologic   More FDA Info for this Device
510(K) Number	K042733
Device Name	Instrument, Quality-Assurance, Radiologic
Applicant	STANDARD IMAGING, INC. 7601 MURPHY DR. MIDDLETON, WI 53562-2766 US Other 510(k) Applications for this Company
Contact	RAYMOND RIDDLE Other 510(k) Applications for this Contact
Regulation Number	892.1940   More FDA Info for this Regulation Number
Classification Product Code	LHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/01/2004
Decision Date	11/15/2004
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