FDA 510(k) Application Details - K093672

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K093672
Device Name	System, Image Processing, Radiological
Applicant	SENTINELLE MEDICAL, INC. 555 RICHMOND STREET W SUITE 800, PO BOX 301 TORONTO, ONTARIO M5V 3B1 CA Other 510(k) Applications for this Company
Contact	JOAN MEDLEY 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	11/27/2009
Decision Date	12/11/2009
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	Y
Expedited Review