FDA 510(k) Application Details - K130692

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K130692
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	ASPECT IMAGING LTD 291 HILLSIDE AVE. SOMERSET, MA 02726 US Other 510(k) Applications for this Company
Contact	George Hattub 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	03/13/2013
Decision Date	01/14/2014
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	N
Expedited Review