FDA 510(k) Application Details - K012490

Device Classification Name	More FDA Info for this Device
510(K) Number	K012490
Device Name	ORION DIGITAL IMAGING SYSTEM
Applicant	INFIMED, INC. 121 METROPOLITAN DR. LIVERPOOL, NY 13088 US Other 510(k) Applications for this Company
Contact	RALPH J FLATAU 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	08/03/2001
Decision Date	02/12/2002
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