FDA 510(k) Application Details - K100335

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K100335
Device Name	System, Image Processing, Radiological
Applicant	OBJECT RESEARCH SYSTEMS, INC. 760 ST-PAUL WEST SUITE 101 MONTREAL, QUEBEC H3C 1M4 CA Other 510(k) Applications for this Company
Contact	ERIC FOURNIER Other 510(k) Applications for this Contact
Regulation Number	892.2050   More FDA Info for this Regulation Number
Classification Product Code	LLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/05/2010
Decision Date	04/08/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	Y
Expedited Review