FDA 510(k) Application Details - K182756

Device Classification Name	System, Nuclear Magnetic Resonance Imaging   More FDA Info for this Device
510(K) Number	K182756
Device Name	System, Nuclear Magnetic Resonance Imaging
Applicant	Myocardial Solutions 3000 RDU Center Drive, Suite 117 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Linda Horne 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	09/28/2018
Decision Date	02/14/2019
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