FDA 510(k) Application Details - K132381

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K132381
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	CLEARMRI SOLUTIONS, INC. W315 S3283 HARVEST VIEW DRIVE WAUKESHA, WI 53189 US Other 510(k) Applications for this Company
Contact	MARY ANN FERGUSON 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	07/31/2013
Decision Date	04/04/2014
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