FDA 510(k) Application Details - K082526

Device Classification Name	System, Image Processing, Radiological   More FDA Info for this Device
510(K) Number	K082526
Device Name	System, Image Processing, Radiological
Applicant	MRI CARDIAC SERVICES, INCORPORATED 8 WEST THIRD ST. SUITE M9 WINSTON-SALEM, NC 27101 US Other 510(k) Applications for this Company
Contact	SCOTT HUBER 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	09/02/2008
Decision Date	01/05/2009
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	N
Expedited Review