FDA 510(k) Application Details - K111373

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K111373
Device Name	System, Image Processing, Radiological
Applicant	CIRCLE CARDIOVASCULAR IMAGING INC. #12, 3535 RESEARCH ROAD NW CALGARY, AB T2L 2K8 CA Other 510(k) Applications for this Company
Contact	SHIRANTHA SAMARAPPULI 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	05/16/2011
Decision Date	08/23/2011
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