FDA 510(k) Application Details - K113337

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K113337
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	MEVIS MEDICAL SOLUTIONS AG N27 W24075 PAUL COURT SUITE 100 PEWAUKEE, WI 53072 US Other 510(k) Applications for this Company
Contact	THOMAS E TYNES 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	11/14/2011
Decision Date	12/30/2011
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