FDA 510(k) Application Details - DEN130012

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130012
Device Name	FERRISCAN R2-MRI ANALYSIS SYSTEM
Applicant	RESONANCE HEALTH ANALYSIS SERVICES PTY LTD 3722 AVE. SAUSALITO IRVINE, CA 92606 US Other 510(k) Applications for this Company
Contact	GREG HOLLAND Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PCS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/2013
Decision Date	01/23/2013
Decision	DENG -
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review