FDA 510(k) Application Details - K173749

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K173749
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	AMRA Medical AB Badhusgatan 5 Linkoping 58222 SE Other 510(k) Applications for this Company
Contact	Janne West 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	12/08/2017
Decision Date	12/06/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review