FDA 510(k) Application Details - K180100

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K180100
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	MRIaudio 2720 Loker Ave., Suite N Carlsbad, CA 92010 US Other 510(k) Applications for this Company
Contact	Joe Caruso 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	01/16/2018
Decision Date	06/14/2018
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