FDA 510(k) Application Details - K083520

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K083520
Device Name	System, Image Processing, Radiological
Applicant	INTELERAD MEDICAL SYSTEMS INCORPORATED 895 DE LA GAUCHETIERE ST WEST, SUITE 400 MONTREAL, QB H3B 4G1 CA Other 510(k) Applications for this Company
Contact	ANIBAL JODORCOVSKY 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	11/26/2008
Decision Date	06/23/2009
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	N
Expedited Review