FDA 510(k) Application Details - K133692

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K133692
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	IMRIS, INC. 5101 Shady Oak Rd Minnetonka, MN 55343 US Other 510(k) Applications for this Company
Contact	Sanjay Shah Other 510(k) Applications for this Contact
Regulation Number	892.1000   More FDA Info for this Regulation Number
Classification Product Code	LNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2013
Decision Date	02/10/2014
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